openFDA Device Event Review Workload Brief

For a medical-device quality or regulatory reviewer, this brief counts FDA MAUDE adverse-event reports received in the latest complete calendar month available from openFDA and the preceding month, for one to five exact three-letter device product codes. It includes up to five recent report IDs per code to open in FDA source data. This is a report-intake and human-review queue aid, not a device safety ranking, failure rate, clinical recommendation, causal finding or regulatory conclusion. FDA reports can be incomplete, late, duplicated or revised.

Input

productCodes accepts one to five uppercase three-letter FDA product codes, default LKK and NRY. Each code is checked against FDA device classification before counting. The Actor reads meta.last_updated and chooses the latest complete calendar month before the refresh month, plus the preceding month. It does not use a partial current month.

Output

One row per validated code includes FDA generic device name, source refresh date, two YYYY-MM month windows, total report counts, event-type count dictionaries, absolute count difference, and up to five recent report keys, received dates, coded event types and FDA links. A confirmed zero-month count is a real negative report-intake observation, not a safety claim. Report counts must never be interpreted as incidence, prevalence, comparative safety or causation. Rows are not risk ranked. No patient, reporter or manufacturer contact, narrative or raw source body is retained.

Pricing

One device-code-brief-created PPE event at $0.005 per delivered row, including a validated zero-month brief. A two-code default produces two dataset rows and two primary events for $0.010; no start or secondary event. Any failed classification/source request prevents all output and charge.

Limits

At most five codes and 21 HTTPS requests; 256 MB, 180 seconds, 20-second per-request timeout, sequential at least one second apart, no browser, proxy, paid API or key. FDA no-key quotas apply to the shared egress IP. Only exact structured NOT_FOUND / No matches found! for a validated code and month means zero; 401/403, 429, 5xx, unexpected 404, malformed JSON, changed count shape or timeout fails explicitly. Source counts may change as FDA updates reports. FDA/openFDA are the source; this Actor is unaffiliated with FDA.

Privacy

Only the FDA product code, generic device name, grouped counts, refresh date, and up to five report keys/dates/coded types/source links are returned. Patient demographics, narratives, reporter identities, manufacturer contacts, addresses, raw JSON and logs of source bodies are omitted.