Adverse Event Reporting Data Files
Manufacturer and User Facility Device Experience (MAUDE) data
MAUDE data are reports 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. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19.
Medical Device Reporting (MDR) data
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.