Bibliothèque

openFDA MAUDE device safety signals (agent-curated)

openFDA MAUDE device-manufacturer safety signals (quarterly)

Quarterly device-safety reporting signals for the top ~500 medical-device manufacturers in the FDA MAUDE database, from the official keyless openFDA device/event API. Per manufacturer for the latest complete calendar quarter: report counts (total, serious = Death+Injury, death), serious and death shares, quarter-over-quarter report growth vs the prior quarter, a z-score of report volume against the manufacturer's own trailing-8-quarter baseline, and a documented 0-100 safety-signal composite (35% min-max(log1p(volume)) + 35% min-max(serious share) + 30% min-max(clipped positive trend)) with deterministic rank and a spike flag (z>=2.0). Only aggregate counts are stored — no individual reports, no patient data. Who joins this: a hospital procurement team joins per-manufacturer serious-event rates and spike flags to their approved-vendor list on manufacturer_name to trigger safety reviews; a medtech competitive-intelligence team joins momentum to its portfolio watch. Caveats: MAUDE is spontaneous reporting, not incidence — no device-utilization denominator, and reporting is biased by recalls, media attention, and manufacturer reporting practices; the score is a reporting-burden triage signal, not a device-safety ranking, and must never drive clinical decisions. Primary key: (manufacturer_name, quarter). Cadence: quarterly.

• health
• signals
• quarterly
• rankings