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Two datasets cover FDA post-market adverse-event reporting:
  • maude: MAUDE reports for medical devices — event type, product problems, device details, patient treatment, and the narrative MDR text.
  • faers: FAERS reports for drugs — the reported reactions (MedDRA terms), seriousness, patient demographics, and the drugs involved with dosage and indication.
Each dataset requires its own Evidence scope. See the Evidence overview for how scopes work.

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Search MAUDE (devices)

Each item in results includes mdrReportKey, reportNumber, eventType, adverseEventFlag, productProblemFlag, productProblems, a device object (brandName, genericName, deviceName, manufacturerDName, modelNumber, deviceClass, regulationNumber), a patient object, and mdrText — the narrative event descriptions. s accepts _relevance (default), date_received, and date_report.

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Search FAERS (drugs)

Each item in results includes safetyreportid, an event object (serious, seriousnessType, receiptdate, patient age/sex/weight fields), a reaction array with MedDRA preferred terms (reactionmeddrapt) and outcomes, a drug array (medicinalproduct, activesubstancename, drugindication, dosage fields, brandName, genericName), and primarysource (reporter qualification and country).

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Single report

GET /api_partner/evidence/maude/{report_id} and GET /api_partner/evidence/faers/{report_id} return one full report each.

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Common uses

  • Signal monitoring: facet by reaction term or product problem over time via the facets endpoint to spot emerging safety signals.
  • Due diligence: pull the adverse-event history for a specific device model or drug substance before a deal, launch, or formulary decision.
  • Literature triangulation: FAERS literaturereference fields and Scite Search let you connect spontaneous reports to published case reports.
Adverse-event reports are spontaneous and unverified; report counts reflect reporting behavior as much as true incidence. Treat them as signals to investigate, not incidence rates.