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  1. Medical Device Reporting (MDR): How to Report Medical Device Problems

MDR Data Files

Each year, the FDA receives over two million medical device reports of suspected device-associated deaths, serious injuries, and malfunctions. These medical device reports have been available in the FDA's public Manufacturer and User Facility Device Experience (MAUDE) Database since 1999 as one source of information to help patients and health care providers make more informed medical decisions.

On this page, the FDA is also providing the medical device reports received from 1984 - 1996 through CDRH's legacy Device Experience Network (DEN) reporting system and reports received under the Alternative Summary Reporting Program from 1999 – April 2019.

Under the Freedom of Information and Privacy Acts (Sec. 552, Title 5, USC) (PL 93-579), the FDA is required to delete, prior to public disclosure, any information that constitutes trade secrets, and confidential, commercial, or financial information; and any personal, medical, and similar information that would constitute a clearly unwarranted invasion of personal privacy. Included in the deletion requirements are all identification of the reporters of the events and the user facility where the event occurred.

On this page:

MAUDE Data Downloadable Files

This section provides downloadable zipped data files that consist of:

  • Voluntary reports since June 1993
  • User facility reports since 1991
  • Distributor reports since 1993
  • Manufacturer reports since August 1996

This data is provided in zip files, which are updated monthly.

The MDR data is presented in tables and contains all publicly available information from the completed the MEDWATCH Form 3500. The FDA recommends downloading all types of files for the time period of interest.

Tip for Downloading Files

  • When downloading the MDR data files to a database such as Microsoft Access, we recommend that you first open, then save the data file in Microsoft WORD. This will add an "end of record" marker to each MDR record that can be recognized by Microsoft ACCESS. For files such as the FOIDEV files, you may need to put in an extra character at the end of the first record prior to importing the file, otherwise the last column of data may be lost.

Tips for Reviewing the Downloaded Files

  • Field Definitions:
    • Master Event Data: A distinct master event data record will be present for each source reporting an event. In other words, if a User Facility, Distributor, Manufacturer, and voluntary submitter all report an event, there will be four event records.
    • Device Data: Contains information related to the device(s) involved in the event.
    • Patient Data: Contains information related to the patient(s) involved in the event.
    • Text Data: Contains textual information from MEDWATCH Form Sections B5, H3, and H10.
    • Device Problem Data: Contains Device Problem Code data from MEDWATCH Form Sections F10 and H6
    • Patient Problem Data: Contains Health Effect – Clinical Code (previously labeled "Patient Code") data from MEDWATCH Form Sections F10 and H6
  • All record types are linked by the MDR REPORT KEY, found in each file.
  • For distributor reports that also had subsequent manufacturer reports, a special data element, MANUFACTURER LINK FLAG, will be set to 'Y'. In this case, the DISTRIBUTOR information (Section F on the master event data record) will be present; otherwise, these data elements will be blank.

The following files are available: (File Sizes are approximate)

 

 

File NameCompressed Size in BytesUncompressed Size in BytesTotal RecordsDescription
mdrfoithru2023.zip598951KB5800337KB18118160Master Record through 2023
mdrfoi.zip78032KB698230KB2162186MAUDE Base records received to date for 2024
mdrfoiadd.zip8281KB78290KB245307New MAUDE Base records for the current month.
mdrfoichange.zip16275KB141156KB435700MAUDE Base data updates: changes to existing Base data.
foidevthru1997.zip6001KB31217KB136917Device Data through 1997
foidev1998.zip3205KB17539KB63440Device Data for 1998
foidev1999.zip2764KB14798KB52880Device Data for 1999
device2000.zip1932KB9998KB53114Device Data for 2000
device2001.zip2126KB11075KB59073Device Data for 2001
device2002.zip2321KB12967KB70384Device Data for 2002
device2003.zip2527KB14242KB77949Device Data for 2003
device2004.zip2803KB14944KB82887Device Data for 2004
device2005.zip3350KB17711KB99770Device Data for 2005
device2006.zip3966KB21308KB120486Device Data for 2006
device2007.zip4820KB30277KB172205Device Data for 2007
device2008.zip5521KB34034KB195474Device Data for 2008
device2009.zip6724KB43739KB243108Device Data for 2009
device2010.zip8724KB56054KB304407Device Data for 2010
device2011.zip11585KB80802KB446880Device Data for 2011
device2012.zip13376KB88104KB487770Device Data for 2012
device2013.zip17746KB124537KB682402Device Data for 2013
device2014.zip20349KB159694KB863841Device Data for 2014
device2015.zip23406KB169708KB862910Device Data for 2015
device2016.zip26283KB180365KB868406Device Data for 2016
device2017.zip31495KB206501KB938709Device Data for 2017
device2018.zip37399KB236717KB1050403Device Data for 2018
device2019.zip45885KB307984KB1333450Device Data for 2019
device2020.zip50739KB363248KB1567544Device Data for 2020
device2021.zip60940KB461286KB2031120Device Data for 2021
device2022.zip73861KB659204KB2949899Device Data for 2022
device2023.zip73369KB531420KB2342112Device Data for 2023
device.zip70894KB491804KB2163224Device Data received to date for 2024
deviceadd.zip8288KB56939KB245225New MAUDE Device data for the current month.
devicechange.zip15232KB100942KB435622Device data updates: changes to existing Device data and additional Device data for existing Base records.
deviceproblemcodes.zip13KB34KB882Device Problem Codes
foidevproblem.zip53179KB293534KB20578598Device Problem Data
foitextthru1995.zip3561KB16551KB27401Narrative data through 1995
foitext1996.zip2782KB9318KB32059Narrative Data for 1996
foitext1997.zip7557KB26382KB91009Narrative Data for 1997
foitext1998.zip5924KB20773KB68316Narrative Data for 1998
foitext1999.zip4501KB15788KB51119Narrative Data for 1999
foitext2000.zip4760KB16491KB52625Narrative Data for 2000
foitext2001.zip5090KB17763KB57986Narrative Data for 2001
foitext2002.zip6089KB22304KB64859Narrative Data for 2002
foitext2003.zip6221KB23332KB66241Narrative Data for 2003
foitext2004.zip6090KB21742KB56117Narrative Data for 2004
foitext2005.zip9649KB34692KB95044Narrative Data for 2005
foitext2006.zip20092KB69183KB177414Narrative Data for 2006
foitext2007.zip25177KB88484KB232627Narrative Data for 2007
foitext2008.zip28286KB101218KB264972Narrative Data for 2008
foitext2009.zip40869KB147687KB388042Narrative Data for 2009
foitext2010.zip62269KB252984KB635654Narrative Data for 2010
foitext2011.zip94583KB425073KB1040278Narrative Data for 2011
foitext2012.zip108957KB475208KB1167621Narrative Data for 2012
foitext2013.zip139507KB622562KB1609332Narrative Data for 2013
foitext2014.zip164295KB788040KB1948365Narrative Data for 2014
foitext2015.zip184834KB861735KB2073784Narrative Data for 2015
foitext2016.zip194760KB924811KB2180342Narrative Data for 2016
foitext2017.zip216530KB1076093KB2365712Narrative Data for 2017
foitext2018.zip213901KB1085673KB2629641Narrative Data for 2018
foitext2019.zip318909KB1795845KB3467112Narrative Data for 2019
foitext2020.zip333059KB2020564KB4016412Narrative Data for 2020
foitext2021.zip385528KB2287987KB4866625Narrative Data for 2021
foitext2022.zip463808KB3305671KB6623615Narrative Data for 2022
foitext2023.zip499585KB3192805KB5406877Narrative Data for 2023
foitext.zip423247KB2496230KB4803780Narrative Data received to date for 2024
foitextadd.zip35295KB227213KB479035New MAUDE Narrative data for the current month.
foitextchange.zip63394KB382728KB670110Narrative data updates: changes to existing narrative data and additional narrative data for existing base records.
patientthru2023.zip95313KB687674KB18104231Patient Record through 2023
patient.zip12345KB92172KB2160971MAUDE Patient records received to date for 2024
patientadd.zip1367KB10331KB245228New MAUDE Patient records for the current month.
patientchange.zip1537KB10808KB264840MAUDE Patient data updates: changes to existing Base data.
patientproblemdata.zip17KB39KB1127MAUDE Patient Problem Codes
patientproblemcode.zip134032KB1130935KB20457749MAUDE Patient Data for Patient Problem Codes

[Accessibility]

Note: This documentation is intended to be used in conjunction with a copy of Medwatch Form 3500A and 3500.

Record/Data Characteristics:

  • The data has one record per line, with the data fields in a pipe-delimited, (i.e., "|") format
  • All data elements are alpha-numeric
  • All text fields contain whatever data was provided/entered. If no information was provided/entered the field will be left empty. If an asterisk ("*") is present, it represents what was entered on the 3500/3500A.
  • All "FLAG" data elements have the value of "Y" for Yes, "N" for No, or are blank if no data was available/entered.
  • All fields identified as multiply-occurring represent data elements which may have multiple values. Each value will be present in the field, separated by a comma. The word "OTHER" may appear as one of the values if the "Other" box was checked off. If the whole field is blank, no data was reported/entered.
  • Section G CONTACT address information may not necessarily be the address where the device is manufactured.

Special Note for REPORT NUMBER data element:

The REPORT NUMBER data element represents Manufacturer Report Number, Distributor Report Number, or internally-generated voluntary report number, depending on the source of the record.

This REPORT NUMBER field will be blank when:

  • User Facility submitted the report
  • Distributor report has not been followed by a subsequent Manufacturer report.

Special Notes for Voluntary Reports and User Facility Malfunction Reports:

The only data elements which will be present on the Master Event Record will be:

  • NEW RECORD
  • DEVICE EVENT KEY
  • REPORT SOURCE CODE
  • MDR REPORT KEY
  • Section B

All other data elements will be blank.

MDRFOI file contains following 82 fields, delimited by pipe (|), one record per line:

  1. MDR Report Key
  2. Empty field (not used)
  3. Report Number
  4. Report Source Code
    • P = Voluntary report
    • U = User Facility report
    • D = Distributor report
    • M = Manufacturer report
  5. Manufacturer Link Flag (internal information flag)
  6. Number Devices in Event (if source code is 'P', field will be null)
  7. Number Patient in Event (if source code is 'P', field will be null)
  8. Date Received

SECTION-B

  1. Adverse Event Flag (B1)
  2. Product Problem Flag (B1)
  3. Date Report (B4)
  4. Date of Event (B3) -- new added, 2006
  5. Single Use Flag (Reprocessor Flag) (D8) -- new added, 2006
  6. Reporter Occupation Code (E3) -- new added, 2006

* INVALID DATA

  • 000 OTHER
  • 001 PHYSICIAN
  • 002 NURSE
  • 003 NON-HEALTHCARE PROFESSIONAL
  • 0HP HEALTH PROFESSIONAL
  • 0LP LAY USER/PATIENT
  • 100 OTHER HEALTH CARE PROFESSIONAL
  • 101 AUDIOLOGIST
  • 102 DENTAL HYGIENIST
  • 103 DIETICIAN
  • 104 EMERGENCY MEDICAL TECHNICIAN
  • 105 MEDICAL TECHNOLOGIST
  • 106 NUCLEAR MEDICINE TECHNOLOGIST
  • 107 OCCUPATIONAL THERAPIST
  • 108 PARAMEDIC
  • 109 PHARMACIST
  • 110 PHLEBOTOMIST
  • 111 PHYSICAL THERAPIST
  • 112 PHYSICIAN ASSISTANT
  • 113 RADIOLOGIC TECHNOLOGIST
  • 114 RESPIRATORY THERAPIST
  • 115 SPEECH THERAPIST
  • 116 DENTIST
  • 117 NURSE PRACTITIONER
  • 300 OTHER CAREGIVERS
  • 301 DENTAL ASSISTANT
  • 302 HOME HEALTH AIDE
  • 303 MEDICAL ASSISTANT
  • 304 NURSING ASSISTANT
  • 305 PATIENT
  • 306 PATIENT FAMILY MEMBER OR FRIEND
  • 307 PERSONAL CARE ASSISTANT
  • 400 SERVICE AND TESTING PERSONNEL
  • 401 BIOMEDICAL ENGINEER
  • 402 HOSPITAL SERVICE TECHNICIAN
  • 403 MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
  • 404 PHYSICIST
  • 405 SERVICE PERSONNEL
  • 499 DEVICE UNATTENDED
  • 500 RISK MANAGER
  • 501 ADMINISTRATOR/SUPERVISOR
  • 600 ATTORNEY
  • 999 UNKNOWN
  • NA NOT APPLICABLE
  • NI NO INFORMATION
  • UNK UNKNOWN

SECTION-E (if source code is 'P', Section E to H will contain no data)

  1. Health Professional (E2)
  2. Initial Report to FDA (E4)
    • Y = Yes
    • N = No
    • U = Unknown
    • * = No answer provided

SECTION-F

  1. Date Facility Aware (F6)
  2. Report Date (F8)
  3. Report to FDA (F11)
  4. Date Report to FDA (F11)
  5. Event Location (F12)
  6. Date Report to Manufacturer (F13)

SECTION-G (only for report source 'M', others sources will be null)

  1. Manufacturer Contact Title Name (G1)
  2. Manufacturer Contact First Name (G1)
  3. Manufacturer Contact Last Name (G1)
  4. Manufacturer Contact Street 1 (G1)
  5. Manufacturer Contact Street 2 (G1)
  6. Manufacturer Contact City (G1)
  7. Manufacturer Contact State Code (G1)
  8. Manufacturer Contact Zip Code (G1)
  9. Manufacturer Contact Zip Code Ext (G1)
  10. Manufacturer Contact Country Code
  11. Manufacturer Contact Postal Code
  12. Manufacturer Contact Phone No Area Code (G1)
  13. Manufacturer Contact Phone No Exchange (G2)
  14. Manufacturer Contact Phone No (G2)
  15. Manufacturer Contact Phone No Ext (G2)
  16. Manufacturer Contact Phone No Country Code
  17. Manufacturer Contact Phone No City Code
  18. Manufacturer Contact Phone No Local
  19. Manufacturer G1 Name (G1)
  20. Manufacturer G1 Street 1 (G1)
  21. Manufacturer G1 Street 2 (G1)
  22. Manufacturer G1 City (G1)
  23. Manufacturer G1 State Code (G1)
  24. Manufacturer G1 Zip Code (G1)
  25. Manufacturer G1 Zip Code Ext (G1)
  26. Manufacturer G1 Country Code
  27. Manufacturer G1 Postal Code
  28. Date Manufacturer Received (G4)

SECTION-H

  1. Device Date Of Manufacture (H4)
  2. Single Use Flag (H5)
  3. Remedial Action (H7) -- multiple source type, separate by ','
    • RC = Recall
    • RP = Repair
    • RL = Replace
    • RB = Relabeling
    • OT = Other
    • NO = Notification
    • IN = Inspection
    • PM = Patient Monitoring
    • MA = Modification/Adjustment
    • * = Invalid Data
  4. Previous Use Code (H8)
  5. Removal/Correction Number (H9)
  6. Event type (H1) -- only relevant for report sourcetype 'M'
    • D = Death
    • IN = Injury
    • M = Malfunction
    • O = Other
    • * = No answer provided
  7. Distributor Name (F3) -- if report source code = 'M' and
  8. Distributor Address line 1 (F3)
  9. Distributor Address line 2 (F3)
  10. Distributor City (F3)
  11. Distributor State Code (F3)
  12. Distributor Zip Code (F3)
  13. Distributor Zip Code Ext (F3)
  14. Report to Manufacturer (F13)
  15. Manufacturer Name (F14)
  16. Manufacturer Address line 1 (F14)
  17. Manufacturer Address line 2 (F14)
  18. Manufacturer City (F14)
  19. Manufacturer State Code (F14)
  20. Manufacturer Zip Code (F14)
  21. Manufacturer Zip Code Ext (F14)
  22. Manufacturer Country Code (F14)
  23. Manufacturer Postal Code (F14)
  24. Type of Report (F7) !multiple submission type, separate by ','
    • I = Initial submission
    • F = Followup
    • X = Extra copy received
    • O = Other information submitted
  25. Source Type (G3) -- multiple source type, separate by ','
    • 00 Other
    • 01 Foreign
    • 02 Study
    • 03 Literature
    • 04 Consumer
    • 05 Health Professional
    • 06 User facility
    • 07 Company representation
    • 08 Distributor
    • 99 Unknown
    • * Invalid data
  26. Date Added
  27. Date Changed
  28. Reporter Country Code
  29. PMA PMN Number
  30. Exemption Number
  31. Summary Report
  32. NOE Summary
  33. Suppl Dates FDA Received
  34. Suppl Dates MFR Received

DEVICE file contains following 48 fields, delimited by pipe (|), one record per line:

  1. MDR Report Key
  2. Device Event key
  3. Implant Flag -- D6, new added; 2006
  4. Date Removed Flag -- D7, new added; 2006; if flag in M or Y, print Date
    • U = Unknown
    • A = Not available
    • I = No information at this time
    • M = Month and year provided only, day defaults to 01
    • Y = Year provided only, day defaulted to 01, month defaulted to January
  5. Device Sequence No -- from device report table
  6. Date Received (from mdr_document table)

SECTION-D

  1. Brand Name (D1)
  2. Generic Name (D2)
  3. Manufacturer Name (D3)
  4. Manufacturer Address 1 (D3)
  5. Manufacturer Address 2 (D3)
  6. Manufacturer City (D3)
  7. Manufacturer State Code (D3)
  8. Manufacturer Zip Code (D3)
  9. Manufacturer Zip Code ext (D3)
  10. Manufacturer Country Code (D3)
  11. Manufacturer Postal Code (D3)
  12. Device Operator (D5)
  13. Expiration Date of Device (D4)
  14. Model Number (D4)
  15. Catalog Number (D4)
  16. Lot Number (D4)
  17. Other ID Number (D4)
  18. Device Availability (D10)
    • Y = Yes
    • N = No
    • R = Device was returned to manufacturer
    • * = No answer provided
  19. Date Returned to Manufacturer (D10)
  20. Device Report Product Code
  21. Device Age (F9)
  22. Device Evaluated by Manufacturer (H3)
    • Y = Yes
    • N = No
    • R = Device not returned to manufacturer
    • * = No answer provided
  23. Combination Product Flag (G4)
    • Y = Yes
    • N = No
  24. UDI-DI
  25. UDI-Public

BASELINE SECTION (for records prior to 2009)

  1. Baseline brand name
  2. Baseline generic name
  3. Baseline model no
  4. Baseline catalog no
  5. Baseline other id no
  6. Baseline device family
  7. Baseline shelf life contained in label
    • Y = Yes
    • N = No
    • A = Not applicable
    • * = No answer provided
  8. Baseline shelf life in months
  9. Baseline PMA flag
  10. Baseline PMA no
  11. Baseline 510(k) flag
  12. Baseline 510(k) no
  13. Baseline preamendment
  14. Baseline transitional
  15. Baseline 510(k exempt flag
  16. Baseline date) first marketed
  17. Baseline date ceased marketing

PATIENT file contains following 10 fields, delimited by pipe (|), one record per line:

  1. MDR Report Key (from patient report table)
  2. Patient Sequence Number (from patient report table)
  3. Date Received (from mdr_document table)
  4. Sequence Number||','|| Treatment -- multiple source type, separate by ';'
  5. Sequence Number||','|| Outcome -- multiple source type, separate by ';'
    • L - Life Threatening
    • H - Hospitalization
    • S - Disability
    • C - Congenital Anomaly
    • R - Required Intervention
    • O - Other
    • * - Invalid Data
    • U - Unknown
    • I - No Information
    • A - Not Applicable
    • D - Death
  6. Patient Age
  7. Patient Sex
  8. Patient Weight
  9. Patient Ethnicity
  10. Patient Race

TEXT file contains following 6 fields, delimited by pipe (|), one record per line:

  1. MDR Report Key
  2. MDR Text Key
  3. Text Type Code (D=B5, E=H3, N=H10 from mdr_text table)
  4. Patient Sequence Number (from mdr_text table)
  5. Date Report (from mdr_text table)
  6. Text (B5, or H3 or H10 from mdr_text table)

FOIDEVPROBLEM contains 2 fields, delimited by pipe (|), one record per line:

  1. Device Problem Code
  2. Problem Description

DEVICEPROBLEMCODES contains 2 fields, delimited by pipe (|), one record per line:

  1. MDR Report Key
  2. Device Problem Code -- (F10) new added; 2006

PATIENTPROBLEMDATA contains following 2 fields, delimited by pipe (|), one record per line:

  1. Patient Problem Code
  2. Problem Description

PATIENTPROBLEMCODE contains following 2 fields, delimited by pipe (|), one record per line:

  1. MDR Report Key
  2. Patient Problem Code

Device Operator Code Key

  • * INVALID DATA
  • 0 OTHER
  • 1 PHYSICIAN
  • 2 NURSE
  • 3 NON-HEALTHCARE PROFESSIONAL
  • 0HP HEALTH PROFESSIONAL
  • 0LP LAY USER/PATIENT
  • 100 OTHER HEALTH CARE PROFESSIONAL
  • 101 AUDIOLOGIST
  • 102 DENTAL HYGIENIST
  • 103 DIETICIAN
  • 104 EMERGENCY MEDICAL TECHNICIAN
  • 105 MEDICAL TECHNOLOGIST
  • 106 NUCLEAR MEDICINE TECHNOLOGIST
  • 107 OCCUPATIONAL THERAPIST
  • 108 PARAMEDIC
  • 109 PHARMACIST
  • 110 PHLEBOTOMIST
  • 111 PHYSICAL THERAPIST
  • 112 PHYSICIAN ASSISTANT
  • 113 RADIOLOGIC TECHNOLOGIST
  • 114 RESPIRATORY THERAPIST
  • 115 SPEECH THERAPIST
  • 116 DENTIST
  • 117 NURSE PRACTIONER
  • 300 OTHER CAREGIVERS
  • 301 DENTAL ASSISTANT
  • 302 HOME HEALTH AIDE
  • 303 MEDICAL ASSISTANT
  • 304 NURSING ASSISTANT
  • 305 PATIENT
  • 306 PATIENT FAMILY MEMBER OR FRIEND
  • 307 PERSONAL CARE ASSISTANT
  • 400 SERVICE AND TESTING PERSONNEL
  • 401 BIOMEDICAL ENGINEER
  • 402 HOSPITAL SERVICE TECHNICIAN
  • 403 MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
  • 404 PHYSICIST
  • 405 SERVICE PERSONNEL
  • 499 DEVICE UNATTENDED
  • 500 RISK MANAGER
  • 501 ADMINISTRATOR/SUPERVISOR
  • 600 ATTORNEY
  • 999 UNKNOWN
  • NA NOT APPLICABLE
  • NI NO INFORMATION
  • UNK UNKNOWN

Event Location Code Key

  • * INVALID DATA
  • 000 OTHER
  • 001 HOSPITAL
  • 002 HOME
  • 003 NURSING HOME
  • 004 OUTPATIENT TREATMENT FACILITY
  • 005 OUTPATIENT DIAGNOSTIC FACILITY
  • 006 AMBULATORY SURGICAL FACILITY
  • 500 HOSPITAL
  • 501 CATHETERIZATION SUITE
  • 502 CRITICAL CARE UNIT
  • 503 DIALYSIS UNIT
  • 504 EMERGENCY ROOM
  • 505 EXAMINATION ROOM
  • 506 LABORATORY/PATHOLOGY DEPARTMENT
  • 507 MATERNITY WARD - NURSERY
  • 508 OPERATING ROOM
  • 509 OUTPATIENT CLINIC/SURGERY
  • 510 PATIENT'S ROOM OR WARD
  • 511 RADIOLOGY DEPARTMENT
  • 600 AMBULATORY HEALTH CARE FACILITY
  • 601 AMBULATORY SURGICAL CENTER
  • 602 BLOOD BANK
  • 603 BLOODMOBILE
  • 604 CATHETERIZATION LAB - FREE STANDING
  • 605 CHEMOTHERAPY CENTER
  • 606 CLINIC - WALK IN, OTHER
  • 607 DIALYSIS CENTER
  • 608 DRUG CLINIC
  • 609 IMAGING CENTER - MOBILE
  • 610 IMAGING CENTER - STATIONARY
  • 611 LABORATORY
  • 612 MOBILE HEALTH UNIT
  • 613 MRI CENTERS
  • 614 PSYCHIATRIC CENTER - WALK IN, OTHER
  • 615 TUBERCULOSIS CLINIC
  • 616 URGENT CARE CENTER
  • 617 OUTPATIENT DIAGNOSTIC FACILITY
  • 700 LONG-TERM CARE FACILITY
  • 701 HOSPICE
  • 702 NURSING HOME
  • 703 PSYCHIATRIC FACILITY
  • 704 REHABILITATION CENTER
  • 705 RETIREMENT HOME
  • 810 PATIENT'S HOME
  • 820 IN TRANSIT TO USER/MEDICAL FACILITY
  • 830 PUBLIC VENUE
  • 831 OUTDOORS
  • 832 PARK
  • 833 PLAYGROUND
  • 834 PUBLIC BUILDING
  • 835 SCHOOL
  • 836 STREET
  • 999 UNKNOWN
  • NA NOT APPLICABLE
  • NI NO INFORMATION
  • UNK UNKNOWN

Alternative Summary Reports

On February 18, 2022, the FDA posted the available Patient Problem Codes associated with legacy Alternative Summary Report (ASR) files on FDA.gov. The 2022 update followed the addition of Patient Problem Codes to the public Manufacturer and User Facility Device Experience (MAUDE) database in September 2020 to provide additional information on the nature of adverse events and related devices, when available.

The Alternative Summary Reporting (ASR) Program was in effect from 1997 through June 2019. In June 2019, the FDA formally ended the Alternative Summary Reporting (ASR) Program and revoked all such exemptions. All reports received under ASR exemptions from 1999 to April 2019 (when the FDA last received reports under the ASR program) are available in the legacy data files linked below. Reports received under the ASR Program from 1999 – April 2019 are not available in MAUDE and are therefore provided on this page.

For more information, see the 2019 Statement on agency's efforts to increase transparency in medical device reporting.

By law, manufacturers may request exemptions, variances or alternatives to reporting requirements under 21 CFR 803.19. Under this provision, the FDA had allowed alternative summary reports (ASRs) for specific well-known and well-characterized events associated with specific devices.

It is important to note that data in ASRs are subject to the same limitations as MDR data in the MAUDE database; they are based on the same threshold for reporting and differ in format. This passive reporting system relies on information provided by users of the devices and other sources, and therefore some information about certain events may be missing, inaccurate, or unverified. Manufacturers are responsible for following up to obtain missing information, but it is not always possible to track down details of an event. Therefore, some fields in both the MAUDE database and ASR reports may be blank. Like all MDR data in the MAUDE database, MDR data in ASR reports cannot be used to determine rates of adverse events due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. In addition, the number of events may fluctuate over time for a variety of reasons that do not reflect a change in the actual rate of the events, such as changes in technology that impact rate of use in clinical practice, changes in a firm's reporting processes, and following a public communication or media reports about a technology. Moreover, the presence of an event or multiple events does not necessarily mean there is a problem with a device. Often additional investigation and data collection are necessary to make that determination.

ASR exemptions excluded events where the device may have caused or contributed to a patient death from being submitted in ASRs, except for sudden death associated with cardiac arrest for certain surgical heart valves when the device had been implanted for at least five years and the event did not necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health.

When an ineligible event was reported through an ASR, the FDA's standard practice was to contact the manufacturer to obtain additional information regarding the event. If the event was labeled in error, the manufacturer was asked to submit a supplemental ASR to correct it. If an event was ineligible for reporting as an ASR, the FDA's standard practice was to require the manufacturer to submit an individual report in MAUDE for the event. In some cases, the FDA revoked ASR exemptions following continued reporting of ineligible events in ASRs.

In some cases, manufacturers also submitted supplemental ASRs providing additional information, such as following an investigation into an event. The supplemental ASRs may include only new information; fields where information did not change from the original ASR may be blank. Both original and supplemental ASRs are posted on our website. Supplemental reports are identified, and caution should be taken so as not to count the same events twice when they appear in both a supplemental and original report.

ASR reports were not made publicly available before 2019 because they were not submitted in a format compatible with the public MAUDE database. The FDA recognized the public interest in this information and modified the conditions of the ASR Program in 2017 to require submission of a companion report on the official mandatory reporting form. The companion report included the total number of events being summarized in the quarterly report through the ASR Program and is available publicly in the MAUDE database. When both an ASR and companion report were submitted, the same events were captured in both systems. Therefore, adding events from ASR and companion reports will result in some double counting.

The following files contain ASR data by reporting year, comprising over six million records in total. Each file is large and contains all ASRs received for that year. As such, these are compressed data files using the zip format. After files are downloaded, they should be unzipped. The unzipped .CSV files can be viewed with a spreadsheet or database software. The ASR data has one record per line, with the data fields in the following comma-delimited format:

Exemption Number,Manufacturer Registration Number,Manufacturer Name,Report ID,Date of Event,Manufacturer Aware Date,Event Type,Device Problem Codes,Report Year,Report Quarter,Initial Report Flag,Device ID,Product Code,Brand Name,Model Number,Catalog Number,Implant Available for Evaluation,Implant Returned to Manufacturer

Following are the compressed MDR data files received from Alternative Summary Reports listed with their compressed and uncompressed file sizes for each year. The data for each year is sorted by product code, exemption number, and quarter.

In February 2022, the FDA added an addendum file containing the Patient Problem Codes for all years of legacy ASR data (1999-2019). The Patient Problem Code records contained in the ASR_PPC file have a one-to-one mapping with the records in the ASR yearly files, based on the Exemption Number, Report ID, Product Code, Report Year, and Report Quarter columns. The ASR_PPC zip file has the same format as the yearly ASR files, with the data fields in the following comma-delimited format: Exemption Number, Report ID, Product Code, Report Year, Report Quarter, Patient Problem Codes. Due to the large size, the addendum file should be opened in database software, such as Microsoft Access, along with the ASR yearly files. This update followed the addition of patient problem codes to the public MAUDE database in September 2020 to provide additional information on the nature of adverse events and related devices, when available.

File nameCompressed SizeUncompressed Size
ASR_1999.zip75KB1.0MB
ASR_2000.zip0.3MB5.7MB
ASR_2001.zip0.5MB8.5MB
ASR_2002.zip0.6MB10MB
ASR_2003.zip0.7MB11MB
ASR_2004.zip0.9MB13MB
ASR_2005.zip0.9MB14MB
ASR_2006.zip3.3MB52MB
ASR_2007.zip3.5MB54MB
ASR_2008.zip3.3MB51MB
ASR_2009.zip3.6MB55MB
ASR_2010.zip3.5MB53MB
ASR_2011.zip3.4MB52MB
ASR_2012.zip3.8MB57MB
ASR_2013.zip3.7MB55MB
ASR_2014.zip3.8MB56MB
ASR_2015.zip3.9MB56MB
ASR_2016.zip4.5MB68MB
ASR_2017.zip3.8MB55MB
ASR_2018.zip1.5MB23MB
ASR_2019.zip83KB0.9MB
ASR_PPC.zip16MB279MB

ASR Data File Values

The below table describes data elements and information contained in the data files. Some fields in some reports may contain blanks or "?" in circumstances where a manufacturer did not have a particular piece of information, the report was supplemental and the information had already been reported, or due to limitations on the text encoding that was accepted when creating the data files. Some reports for silicone-filled breast implants include additional data fields, as required by the FDA as a condition of their summary reporting exemption.

Data ElementColumn HeadingDescription
Exemption Numberexemptn_noThe exemption ID number from the ASR approval letter
Manufacturer Registration Numbermfr_noCFN or FEI belonging to the reporting firm
Manufacturer Namemfr_nameReporting firm name, analogous to G1 Manufacturer Name on the 3500A form
Report IDreport_idUnique identifier for this ASR report. Duplicate values from the same firm in this field indicate initial and supplement reports. Analogous to G9 Manufacturer Report Number on the 3500A form.
Date of Event*date_of_eventThe date of the adverse event. Analogous to B3 Date of Event on the 3500A form.
Manufacturer Aware Datemfr_aware_dateThe date the manufacturer became aware of the adverse event. Analogous to G4 Date Received by Manufacturer on the 3500A form
Event Typeevent_typeThe type of adverse event, analogous to H1 Type of Reportable Event on the 3500A form. The expected values are:
M=Malfunction
M-D=Malfunction where a patient death was reported
IN=Serious Injury
IN-D=Serious Injury where a patient death was reported
D=Death
Device Problem Codesdev_prob_cdA semicolon-delimited list of Device Problem Codes describing the adverse event. Analogous to H6 Device Code on the 3500A form. For the list of expected values and what they mean, see: ASR DPC Terms.csv
Report Yearreport_yearThe submission year for this report
Report Quarterreport_qtrThe submission quarter for this report
Initial Report Flaginitial_report_flagA flag indicating whether the report is an initial or supplement, analogous to G7 Initial/Follow-up on the 3500A form. Note that this field was not provided by the submitter, but rather derived by FDA for ease of data analysis. The expected values are:
I=Initial
S=Supplement
Device IDdev_idThe identifier key for the device in the ASR database, typically a model number or catalog number.
Product Codeproduct_codeThe product code of the device. Analogous to D2 Procode on the 3500A form.
Brand Namebrand_nameThe brand name of the device. Analogous to D1 Brand Name on the 3500A form.
Model Numbermodel_noThe model number of the device. Analogous to D4 Model Number on the 3500A form.
Catalog Numbercatalog_noThe catalog number of the device. Analogous to D4 Catalog Number on the 3500A form.
Implant Available for Evaluation*impl_avail_for_evalFlag indicating whether the device is available for evaluation. Analogous to D10 Device Available for Evaluation Yes/No on the 3500A form. The expected values are:
1=Yes
2=No
7=No Information
Implant Returned to Manufacturer*impl_ret_to_mfrFlag indicating whether the device was returned to the manufacturer. Analogous to the Returned to Manufacturer checkbox under D10 on the 3500A form. The expected values are:
1=Yes
2=No
Patient Problem Codes**pat_prob_cdA semicolon-delimited list of Patient Problem Codes describing the adverse event. Analogous to H6 Patient Code on the 3500A form. For the list of expected values and what they mean, see: ASR PPC Terms.csv

* Field required only for some reports for silicone-filled breast implants as a condition of their summary reporting exemption.
** The Patient Problem Code data element is only available in the ASR_PPCs zip file.

Device Experience Network (DEN) Reports

CDRH's Device Experience Network (DEN) was used by the FDA from 1984 – 1996 to store file reports received under both the mandatory Medical Device Reporting Program (MDR) from 1984 - 1996, and the voluntary reports up to June 1993. These files contain over 600,000 reports.

An on-line search is available which allows you to search for information on medical devices which may have malfunctioned or caused a death or serious injury during the years 1984 through 1996.

The following files contain DEN data listed by the year they were received. Each file is large, and complete for that year. As such, these are compressed data files using the zip format. After files are downloaded, they should be unzipped. The unzipped .TXT files can be viewed with a text editor, spreadsheet or database software. The MDR data has one record per line, with the data fields in the following pipe-delimited, (i.e., "|") format:

Access Type and Number|Date Received|Product Description|Manufacturer name code|Manufacturer Name|Street address|City|State
|Zipcode|Report type|Model number|Catalog number| FDA panel code|FDA Product code|Event description type|Event description|Closeout text

Following are the compressed MDR data files received from CDRH's DEN reports listed with their compressed and uncompressed file sizes. The last file listed, disclaim.zip, contains a disclaimer from the manufacturer for each report.

File nameCompressed SizeUncompressed Size
mdr84.zip24KB78KB
mdr85.zip1.7MB10MB
mdr86.zip2.2MB13MB
mdr87.zip2.0MB12MB
mdr88.zip1.9MB11MB
mdr89.zip2.2MB14MB
mdr90.zip3.2MB18MB
mdr91.zip5.0MB30MB
mdr92.zip7.3MB49MB
mdr93.zip8.5MB56MB
mdr94.zip8.5MB63MB
mdr95.zip8.6MB47MB
mdr96.zip8.5MB42MB
mdr97.zip11.0KB45KB
disclaim.zip163KB2MB
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