Recognize and Report Device Problems
This page provides resources for healthcare providers about reporting problems with medical devices to FDA. These resources may be used as educational tools for healthcare staff in-service/training to encourage medical device reporting so as to enhance patient safety outcomes.
Recognize, Remove, Report Video
The 9-minute Recognize, Remove, Report video illustrates why it is so important for healthcare providers to recognize when medical device problems occur.The video is also available online in these formats:
The following materials may be used to educate healthcare provider staff representing specific clinical areas about the importance of reporting medical device problems:
- Improving Patient Safety by Reporting Problems with Medical Devices – Home Version
- Improving Patient Safety by Reporting Problems with Medical Devices - General Version
- Improving Patient Safety by Reporting Problems with In Vitro Diagnostic Devices - Lab Version
- Improving Patient Safety by Reporting Problems with Medical Devices - Pediatric Version
- Improving Patient Safety by Reporting Problems with Medical Devices - Operating Room Version
How and Where to Report
- Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities
- Medical Device Reporting (MDR) - Contact Information for User Facilities and Manufacturers
- Medical Device Reporting for User Facilities (PDF - 313KB)
- Medical Device Reporting Regulation History
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program