FAIRsharing record for: Manufacturer and User Facility Device Experience Database

This FAIRsharing record describes: The Manufacturer and User Facility Device Experience (MAUDE) database represents reports of adverse events involving medical devices. MAUDE contains the last 10 years of medical device report (MDR) data. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19. The downloadable data files consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996.
The public may search the database for information on medical devices that may have malfunctioned or caused a death or serious injury. Data for the past 10 years is available through the end of the previous month. The FDA seeks to include all reports received prior to each monthly update. Data more than 10 years old through 1995 is available in zip files by year.