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MAUDE

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Manufacturer and User Facility Device Experience

MAUDE contains reports of adverse events involving medical devices submitted to the U.S. FDA by manufacturers, importers, and user facilities. This MCP lets an AI assistant search, retrieve, and aggregate those reports directly — no manual form-filling on the FDA site. Beyond keyword search, it also lets an assistant search by meaning — finding relevant events by concept even when the wording differs.

Connect

MCP endpoint
https://mcp.polarisray.com/maude

Transport: http · Auth: none · See the connection guide for client-specific steps.

Tools

  • search_reports Search MAUDE reports by free text and/or filters — device/brand, manufacturer, product code, event type, date range, and normalized concept facets.
  • semantic_search_reports Search reports by meaning, not just exact keywords — finds relevant adverse events by concept.
  • get_report Retrieve the full detail of a single adverse event report by its MDR key.
  • aggregate_reports Count and group reports by manufacturer, brand, product code, event type, or normalized concept facets — or as a time trend.
  • top_problems Surface the most common device or patient problem descriptions across a matching set of reports.
  • resolve Normalize lay terms and abbreviations to standard medical terms, for precise filtering.

Example questions

  • "How many adverse events were reported for insulin pumps in 2023?"
  • "Find reports about an insulin pump delivering the wrong dose."
  • "Show me malfunction reports for Medtronic pacemakers, most recent first."
  • "Which manufacturers have the most reported device deaths this year?"

About this dataset

The MAUDE database houses medical device reports (MDRs) of suspected device-associated deaths, serious injuries, and malfunctions. It is one of the FDA’s primary post-market surveillance tools.

What you can ask

Once connected, ask your assistant plain-English questions — it translates them into the underlying searches and returns structured results. Hits include an official url to the FDA MAUDE detail page so you can verify each report.

Search by meaning

Beyond keyword search, PolarisRay can search reports by meaning rather than exact words. Ask for reports “about” or “similar to” a problem and it surfaces conceptually related adverse events even when the narrative is phrased differently — and the usual filters (device, manufacturer, event type, …) still apply.

Caveats

MAUDE data has known limitations: underreporting, inconsistent data quality, and duplicate reports are common. Counts should be treated as signals, not statistics. Always confirm findings against the primary report and the FDA’s own guidance before drawing conclusions.

Why PolarisRay

Fewer tokens. Search by meaning.

Answer-ready results with far less context than raw APIs — plus concept search the official FDA API can't do.

See why PolarisRay →