Fda Medical Device Problems

Medical Device Reporting (MDR): How to Report Medical …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

Submit reports to the FDA through the MedWatch program in one of the following ways: Complete the MedWatch Online Reporting Form. Download form or call 1-800-332-1088 to request a reporting form ...

Seven serious medical device malfunctions that have led to …

https://www.nsmedicaldevices.com/analysis/medical-device-failures-fda-recalls/

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

CDRH 2022 Annual Report. Accomplishments for 2022, including the Pandemic Response, MDUFA V, Device Innovation, over-the-counter (OTC) hearing aid final rule, and device …

Medical Device Safety | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/medical-device-safety

Medical Device Safety. The FDA monitors reports of adverse events and other …

MAUDE - Manufacturer and User Facility Device …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters …

Product Problems | FDA - U.S. Food and Drug …

https://www.fda.gov/safety/reporting-serious-problems-fda/product-problems

Product Problems. Product problems should be reported to the FDA when there is a concern about the quality, authenticity, performance, or safety of any medication or …

Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls

Summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could …

Report a Problem to the FDA | FDA - U.S. Food and …

https://www.fda.gov/safety/report-problem-fda

Timely reporting by consumers, health professionals, and FDA-regulated companies allows the agency to take prompt action. The agency evaluates each report to …

MDR Adverse Event Codes | FDA

https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/mdr-adverse-event-codes

The FDA Medical Device Report (MDR) adverse event codes are collectively a system of codes, terms, and definitions used to describe and categorize medical device adverse …

Coding Resources for Medical Device Reports | FDA

https://www.fda.gov/medical-devices/mdr-adverse-event-codes/coding-resources-medical-device-reports

Medical Device Problem: Annex A: Medical Device Component: Annex G: Cause Investigation - Type of Investigation: ... The list below contains summaries of …