Adverse events now carry IMDRF problem codes
Every adverse-event report we index now carries the manufacturer's coded problem terms, mapped to the IMDRF adverse-event terminology. Previously that coding was dropped on the floor — the ingest read a field openFDA doesn't publish, so the column sat empty on all 4.6M reports.
- 8.6M problem tags backfilled across 3.68M reports — 79% of indexed events, on both the device-problem and patient-effect axes.
- New Problem Trends view: the most-reported device problems across your monitored product codes, with movement against the previous window.
- Each problem opens a detail view — manufacturer and product-code breakdown, week-by-week volume against the prior period, event-type split, and links out to the source MAUDE records.
- Signal detail and the inbox now show the coded problems behind an MDR spike, so a spike reads as what went wrong, not just how often.
Counts are reported events, not failure rates — MAUDE has no denominator. Coding is manufacturer-reported and descriptive: we surface the observational annexes only, and assert nothing about cause.
(Thanks to A.S.)