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tooluniverse-product-safety-surveillance

Retrieve FDA post-market safety records for devices, food, supplements, veterinary drugs, and shortages via openFDA.

1.7k|254|Updated Mar 3, 2025
Search Tags:#pharmacovigilance#device recalls#drug shortages#adverse events#OpenFDA#maude#caers
One-click install
npx skills add https://github.com/mims-harvard/ToolUniverse --skill tooluniverse-product-safety-surveillance
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: tooluniverse-product-safety-surveillance
Source: https://github.com/mims-harvard/ToolUniverse/tree/main/plugins/tooluniverse/skills/tooluniverse-product-safety-surveillance
Command: npx skills add https://github.com/mims-harvard/ToolUniverse --skill tooluniverse-product-safety-surveillance

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes references (resource) components.

What problem does it solve?

Finding post-market safety information for FDA-regulated products other than drugs requires navigating many separate openFDA endpoints (MAUDE device events, CAERS food/supplement reports, veterinary adverse events, drug shortages, enforcement recalls), each with its own fields and Lucene query syntax. This Skill selects the right endpoint, builds valid queries, and interprets the returned records with proper safety-reporting caveats.

Core Features & Use Cases

  • Multi-product retrieval: Query device adverse events (MAUDE), device recalls and 510(k) clearances, food/supplement/cosmetic CAERS reports, veterinary drug adverse events, drug shortages, and cross-product enforcement/recall reports through ToolUniverse openFDA tools.
  • Query grammar guidance: Build valid field-scoped Lucene queries (space-separated AND, dot-path nested fields, correct date formats) and avoid syntax that breaks openFDA requests.
  • Interpretation tables: Map raw openFDA fields (event_type, classification, VeDDRA terms, shortage status) to their regulatory meaning, with mandatory limitations on spontaneous-report data.
  • Use Case: Ask whether ketorolac injection is currently in shortage; the Skill queries /drug/shortages.json with dosage_form and status filters and reports the shortage reason, availability, and manufacturer.

Quick Start

Ask the agent to check whether there are any reported deaths in adverse-event reports for pacemakers using the product safety surveillance skill.

Frequently Asked Questions about tooluniverse-product-safety-surveillance

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I search FDA adverse events for a medical device?▼

Use the OpenFDA_search_device_adverse_events tool against the /device/event.json MAUDE endpoint with a field-scoped Lucene query such as device.generic_name:pacemaker AND event_type:Death. The response meta.results.total gives the matching report count.

How do I check if a drug is currently in shortage?▼

Query the OpenFDA_search_drug_shortages tool with filters like status:Current and a generic_name or dosage_form value. Returned fields include availability, shortage_reason, company_name, and therapeutic_category for each shortage record.

Can this skill compute drug adverse-event signal scores like PRR or ROR?▼

No. This skill only retrieves and interprets raw safety records; it does not compute disproportionality statistics. For PRR, ROR, or IC signal detection, use the tooluniverse-pharmacovigilance or tooluniverse-adverse-event-detection skills instead.

Why does my openFDA query fail with special characters or +AND+?▼

openFDA queries through these tools require a literal space-separated AND between terms, not +AND+. Values containing parentheses, slashes, or leading plus signs break the query, so use a single simple token such as products.industry_name:Dietary.

What are the limitations of MAUDE and CAERS adverse-event counts?▼

MAUDE and CAERS are passive spontaneous-reporting systems, so counts are unverified report counts, not incidence rates, and carry no exposure denominator. MAUDE also contains duplicate follow-up reports, so report counts should not be treated as distinct event counts.

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