MAUDE - Manufacturer and User Facility Device Experience

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.

• Is updated every month to include reports received through the last day of the previous month.
• May not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19 prior to June 2019. However, these reports, as well as reports older than ten years, can be found on the MDR Data Files webpage.
• Includes a simple search and an advanced search.
  • Simple search allows the user to search on any terms that appear in an MDR received by the FDA in a selected year.
    • Users can enter a single word (e.g., electromechanical), an exact phrase in quotes (for example, "electromechanical pump") or multiple words separated by "and" (for example, bruise and throat and intubation)
    • The device's UDI can also be entered into this field to search based on UDI.
    • The search will return up to 500 results for MDRs received by FDA in the selected year.
  • Advanced search allows a user to search on specific fields such as device brand name, manufacturer, etc. over a specific timeframe.
    • The advanced search will return up to 500 results for MDRs received over the selected timeframe.
    • For larger searches and additional searching options, users may download MDR files from the MDR Data Files webpage.

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.