cff-version: 1.2.0
message: "If you use this dataset, please cite it as: Probative Growth, Medical device adverse event reports by product code and quarter (FDA MAUDE via openFDA), 2026, https://doi.org/10.5281/zenodo.23963431. Source: Probative, Medical device adverse event reports by product code and quarter (FDA MAUDE via openFDA), version 2.0.0, https://doi.org/10.5281/zenodo.23963431, licensed CC BY 4.0."
type: dataset
title: "Medical device adverse event reports by product code and quarter (FDA MAUDE via openFDA)"
authors:
  - name: "Probative Growth"
    website: "https://probativegrowth.com"
version: "2.0.0"
date-released: 2026-11-04
doi: 10.5281/zenodo.23963431
url: "https://probativegrowth.com/data/device-events/"
license: CC-BY-4.0
abstract: "Adverse event reports the FDA received about medical devices, counted by device product code and calendar quarter from 2025 Q1: reports, deaths, injuries, malfunctions and other, for the 300 product codes with the most reports and for all devices together. Counted with the openFDA device event API (licence CC0); no report row, narrative, patient or manufacturer is ever read, only counts. Reports are filed up to weeks after an event and are driven by litigation and recalls as well as by harm, so a count is not an incidence rate."
keywords:
  - "FDA MAUDE adverse event reports by product code"
  - "medical device adverse events by quarter"
  - "device injury reports openFDA"
  - "device recall injury reports trend"
  - "mass tort medical device reports"
  - "MDR counts by device type"
