Wednesday, July 11, 2007

US Food and Drug Administration FDA Manufacturer and User Facility Device Experience Database MAUDE

US Food and Drug Administration FDA Manufacturer and User Facility Device Experience Database MAUDE [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm] - MAUDE data represents 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.

An on-line search is available which allows you to search the CDRH's database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE is scheduled to be updated quarterly and the search page reflects the date of the most recent update. FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed by technical or clerical difficulties. (Descriptive information provided by MAUDE here)

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