Adverse Events Reporting - General Information

Center for Devices and Radiological Health, U.S. Food and Drug Administration

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH
horizonal rule

Adverse Event Reporting Data Files

MAUDE Data (Manufacturer User Facility and Distributor Experience database)

MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996.

MDR Data (Device Experience Network database)

MDR data contains information from CDRH's former database, the device experience network (DEN). The reports include mandatory manufacturer 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 Program (MDR) from 1984 - 1996, and voluntary reports up to June 1993. There are over 600,000 reports.

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.

Updated 9/22/2002

horizonal rule

Center for Devices and Radiological Health / CDRH