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. The dataset is sourced from the FDA's Manufacturer and User Facility Device Experience database.
Use Cases
- Identify trends in medical device malfunctions based on adverse event reports.
- Analyze reporting patterns across different sources (manufacturer, user facility, distributor).
- Monitor post-market safety signals for specific device types based on reported events.
Strengths
- Reports span over three decades, with data starting from 1991.
- Aggregates reports from multiple mandatory and voluntary sources.
Limitations
- Row count is unknown, which may limit suitability assessment.
- Column-level documentation is absent; field semantics must be inferred after download.
- Last update date is unknown; freshness unverified.
Provenance
- Source
- U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience database.
- Collection Method
- Mandatory and voluntary reporting by manufacturers, user facilities, and distributors.
- Time Range
- 1991 to present, with different source types starting in different years.
- Freshness
- null
- Geography
- United States.