MAUDE-Atlas v1.0.0 — Sample (100,003 FDA Medical Device Reports)
Year: 2026
Type: article
Abstract: MAUDE-Atlas v1.0.0 — Full Dataset (25.7M Reports): Full dataset page: https://sentineldata.com.ua/dataset/maude-atlas-fda-medical-device-safety-database-25-7m-reports A non-synthetic global medical-device safety atlas built from the FDA MAUDE database via the openFDA device/event endpoint. Contains 25,711,469 post-market reports, enriched with GUDID (UDI), enforcement recalls, 510(k), PMA, and classification data, and coded with the official FDA MDR adverse-event terminology (embedding IMDRF annex A-G). Features deduplicated clusters (MinHash/LSH, Jaccard >= 0.85), leakage-controlled splits (train/val/test/test_ood with 20% product-code holdout), and ready-to-use benchmarks (severity classification, signal detection, link prediction). This is a free stratified sample of MAUDE-Atlas v1.0.0 100,003 real (non-synthetic) canonical reports, stratified by event_type_std and decade (seed=20260830). The sample includes all linked tables: devices_enriched, patients, mdr_texts, problem codes, event clusters, and splits for the sampled reports, plus the full terminology table. Sample Composition: Reports: 100,003 Patients: 100,009 MDR Texts: 247,259 Patient Problem Codes: 210,946 Key Features: Real FDA MAUDE data (non-synthetic) Stratified by event type and decade Includes full set of linked tables Exact-match problem coding with official FDA MDR terminology Leakage-controlled splits ... Full description with all tables is on the Wiki page of this project. Full dataset and purchase: https://sentineldata.com.ua/dataset/maude-atlas-fda-medical-device-safety-database-25-7m-reports . Zenodo copy: https://doi.org/10.5281/zenodo.22204785
Source: Open Science Framework
Author: Maksym Chekerskyi
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W7225464938