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  4. Medical Device Reporting (MDR): How to Report Medical Device Problems
  5. Adverse Event Reporting Data Files
  1. Medical Device Reporting (MDR): How to Report Medical Device Problems

Adverse Event Reporting Data Files

Manufacturer and User Facility Device Experience (MAUDE) data

MAUDE data contain reports received by the FDA of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996.

For more information:

Please see the MDR Data Files webpage for Device Experience Network (DEN) and Alternative Summary Report (ASR) data received by the FDA.

Medical Device Reporting (MDR) data

Device Experience Network

MDR data contains information from CDRH's former database, the device experience network (DEN). The reports include mandatory manufacturer reports and voluntary reports on devices which may have malfunctioned or caused a death or serious injury. These reports were received under both the mandatory Medical Device Reporting (MDR) Program from 1984 - 1996, and voluntary reports up to June 1993. These data files contain over 600,000 reports.

Alternative Summary Reporting (ASR)

MDR data also contain information received under the ASR Program for mandatory Medical Device Reporting (MDR) from 1999 through April 2019. The summary data includes mandatory manufacturer reports of specific well-known, well-characterized events associated with certain devices where an exemption from the individual reporting requirements was granted. These data files contain over 6 million events.

Please note that the FDA is required under the Freedom of Information and Privacy Acts (SEC 552, Title 5, USC) (PL 93-579) 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.

For more information:

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