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tooluniverse-product-safety-surveillance

Post-market safety surveillance and recall/adverse-event RETRIEVAL across the full spectrum of FDA-regulated products that are NOT covered by the drug-AE signal skills: medical devices, food / dietary supplements / cosmetics, veterinary drugs, and drug supply (shortages). Orchestrates openFDA endpoints (MAUDE device adverse events + device recalls + 510(k), CAERS food/supplement/ cosmetic adverse events, veterinary adverse events, drug shortages, and cross-product enforcement/recall reports). USE WHEN the user asks: "are there adverse events for [device / pacemaker / infusion pump / insulin pump]", "device recalls for [firm/product]", "supplement / vitamin / cosmetic adverse reactions", "is [drug] in shortage", "what injectables are on shortage", "veterinary / animal adverse events for [drug] in [dog/cat/horse]", "food recall for listeria", "MAUDE report for [device]", "CAERS reactions for [brand]". DO NOT USE for drug adverse-event SIGNAL detection or disproportionality (PRR / ROR / IC) or drug-AE association scoring — that is `tooluniverse-pharmacovigilance` / `tooluniverse-adverse-event-detection`. This skill is multi-product surveillance and retrieval, not drug-AE statistical signal mining.

skills/tooluniverse-product-safety-surveillance/SKILL.md

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Nov 8, 2026
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# Product Safety Surveillance (multi-product, openFDA)

Retrieve and interpret post-market safety records across **every FDA-regulated
product class except drug-AE signal mining**: medical devices, food / dietary
supplements / cosmetics, veterinary drugs, and drug supply (shortages), plus
cross-product enforcement/recall reports.

**KEY PRINCIPLES**
1. **Decide the product class first.** Device? Food/supplement/cosmetic? Vet drug? Drug shortage? Recall? The class picks the tool.
2. **Build a valid Lucene query.** openFDA uses field-scoped `field:value` terms; combine with a space-separated `AND`. Phrases and special characters need care (see Query Grammar).
3. **Retrieve, then interpret.** These are spontaneous/voluntary reports. Report the records and their fields; never assert causation or rates.
4. **Cite every record** with the tool name, the openFDA endpoint, the query used, and the `total` hit count from `meta.results.total`.
5. **Stay in scope.** If the request is drug-AE signal detection (PRR/ROR/IC), STOP and point to `tooluniverse-pharmacovigilance` / `tooluniverse-adverse-event-detection`.