{
  "id": 14548893,
  "title": "Medical device adverse event reports are often incomplete, inaccurate and delayed",
  "url": "https://urgent.news/2026/10/14/medical-device-adverse-event-reports-are-often-incomplete-inaccurate",
  "topic": "science",
  "section": "Science",
  "published": "2026-10-14T22:30:26.000Z",
  "source": {
    "name": "Medical Xpress",
    "slug": "medical-xpress",
    "url": "https://medicalxpress.com/news/2026-10-medical-device-adverse-event-incomplete.html"
  },
  "original_language": "en",
  "account": "In a recent study published in The BMJ, it was revealed that medical device manufacturers often submit incomplete, inaccurate, and delayed adverse event reports to the U.S. Food and Drug Administration (FDA). This lack of transparency hampers the ability to promptly detect potential safety issues and may ultimately compromise patient safety. Regulated by the FDA since 2019, medical device manufacturers are required to report malfunctions and adverse events to the Manufacturer And User Facility Device Experience (MAUDE) database within 30 days to facilitate postmarket surveillance and safety measures, such as product recalls. However, the study found that only 57% of the 6,308 adverse event summary reports submitted to the FDA over a six-year period correctly identified a device or use problem, while 38% contained insufficient information and 11% were incorrectly classified as nonsummary reports. Notably, 55% of the reports submitted by manufacturers exceeded the FDA's 30-day reporting deadline. The researchers behind the study emphasize the importance of improving reporting accuracy and timeliness to better protect patients and meet FDA standards.",
  "summary": "Permitting medical device manufacturers to submit bulk summary reports of adverse events to the U.S. Food and Drug Administration (FDA), rather than reporting individual cases, often fails to promptly detect potential safety signals, finds a study published by The BMJ. This is a public health concern, argue the researchers, and they call for immediate improvements to better protect patient safety…",
  "key_points": [],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 1,
    "also_reported_by": []
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}