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FDA MAUDE Database

What do you need to know about the database?

The FDA MAUDE Database is maintained by the U.S. Food and Drug Administration (FDA) and contains reports of adverse events involving medical devices. It includes data submitted by manufacturers, healthcare professionals, and the public, aiming to identify potential safety concerns.

Database Administrator

U.S. Food & Drug Administration

What data are included in the database?

The MAUDE database contains key data on medical device adverse events, including:

1. Event Type: Classification as injury, malfunction, or death.
2. Device Name: The name or type of medical device involved.
3. Manufacturer Information: Details about the device manufacturer.
4. Event Description: Summary of the reported issue, including patient impact.
5. Date of Event: When the adverse event occurred.
6. Date of Report: When the incident was reported to the FDA.
7. Source of Report: Identifies whether the report came from a manufacturer, healthcare facility, or individual.
8. Product Code & Model Number: Identifies the device category and specific model.

How to search the database?

To search the FDA MAUDE Database:

1. Visit the official FDA MAUDE Database.
2. Use search criteria such as device name, manufacturer, event type, date range, product code, or report number.
3. Apply filters for more specific results.
4. Review search results to access detailed adverse event reports.

For related content, visit RELATED DATABASES.