Showing 1 to 1 of 1 items tagged as quality assessment
Provider: U.S. Food and Drug Administration
Contents: government documents, multiple databases, reports
Access Level: Free, Open Access
Descriptions: MAUDE stands for Manufacturer And User Device Experience. Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers. Some information dates back as far as 1991. Updates are posted weekly. Zip file format of Maude data is available for downloading.
Keywords: medical devices, quality assessment, safety, U.S. Government