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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE) Database
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The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
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The Manufacturer and User Facility Device Experience (MAUDE) database is a searchable database of medical device reports (MDRs) of adverse events involving medical devices over the last ten years. Reports older than ten years are provided on the FDA's MDR Data Files webpage.

The MAUDE database:

Additional information about MDR data is available on About Manufacturer and User Facility Device Experience (MAUDE).

1. In accordance with 21 CFR Part 803, manufacturers and importers must submit reports when they become aware of information that reasonably suggests that one of their marketed devices may have caused or contributed to a death or serious injury or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Manufacturers must send reports of such deaths, serious injuries and malfunctions to the FDA. Importers must send reports of deaths and serious injuries to the FDA and the manufacturer, and reports of malfunctions to the manufacturer.

Device user facilities include hospitals, outpatient diagnostic or treatment facilities, nursing homes and ambulatory surgical facilities. Device user facilities must submit reports when they become aware of information that reasonably suggests that a device may have caused or contributed to a death or serious injury of a patient in their facility. Death reports must be sent to the FDA and the manufacturer, if known. Serious injury reports must be sent to the manufacturer or to the FDA, if the manufacturer is not known.
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