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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

2 linked reportsMalfunction 2
11232023-07: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1.5/device2024-08: 0 reports for this device; peer average 1.25/device2024-09: 0 reports for this device; peer average 2.5/device2024-12: 0 reports for this device; peer average 1.13/device2025-01: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 1.25/device2025-10: 0 reports for this device; peer average 1.5/device2025-12: 2 reports for this device; peer average 2.8/device2026-01: 0 reports for this device; peer average 1.5/device2026-03: 0 reports for this device; peer average 1.5/device2026-04: 0 reports for this device; peer average 1.5/device2026-05: 0 reports for this device; peer average 1.6/device0701020809120107101201030405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2023-0701
2024-0101
2024-0201.5
2024-0801.25
2024-0902.5
2024-1201.13
2025-0102
2025-0701.25
2025-1001.5
2025-1222.8
2026-0101.5
2026-0301.5
2026-0401.5
2026-0501.6
This device (reports/month)Average device in PUP (reports/device/month)
Failure-mode summaryAI-generated

2 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-12-229680353-2025-00054MalfunctionAvailablecatalog number

Showing the most recent 1 of 2 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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