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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.

27 linked reportsMalfunction 25Injury 2
24682019-04: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-02: 2 reports for this device; peer average 2/device2025-03: 4 reports for this device; peer average 4/device2025-04: 0 reports for this device; peer average 1/device2025-05: 2 reports for this device; peer average 2/device2025-06: 5 reports for this device; peer average 5/device2025-07: 2 reports for this device; peer average 2/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 2/device2026-01: 8 reports for this device; peer average 4.5/device2026-05: 4 reports for this device; peer average 2.5/device0407040106100408010203040506070809110105
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0401
2019-0701
2021-0401
2022-0101
2023-0601
2023-1002
2024-0401
2024-0801
2025-0101
2025-0222
2025-0344
2025-0401
2025-0522
2025-0655
2025-0722
2025-0802
2025-0902
2025-1102
2026-0184.5
2026-0542.5
This device (reports/month)Average device in FPP (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-05-141523574-2026-00060MalfunctionAvailableexact di
2026-05-121523574-2026-00041MalfunctionAvailableexact di
2026-01-231523574-2026-00014MalfunctionAvailableexact di
2026-01-231523574-2026-00012MalfunctionAvailableexact di
2026-01-081523574-2026-00004MalfunctionAvailableexact di
2026-01-081523574-2026-00001MalfunctionAvailableexact di
2025-07-181523574-2025-00073MalfunctionAvailableexact di
2025-06-251523574-2025-00064MalfunctionAvailablemodel number
2025-06-131523574-2025-00061MalfunctionAvailableexact di
2025-06-061523574-2025-00056MalfunctionAvailableexact di
2025-05-081523574-2025-00054MalfunctionAvailableexact di
2025-03-211523574-2025-00044MalfunctionAvailableexact di
2025-03-211523574-2025-00033MalfunctionAvailableexact di
2025-02-131523574-2025-00012InjuryAvailableexact di

Showing the most recent 14 of 27 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2023-01-24VAIVoluntary action indicatedFerno-Washington Inc6
2023-01-24VAIVoluntary action indicatedFerno-Washington Inc6
2018-07-23NAINo action indicatedFerno-Washington Inc0
2018-07-23NAINo action indicatedFerno-Washington Inc0
2015-03-11VAIVoluntary action indicatedFerno-Washington Inc6
2015-03-11VAIVoluntary action indicatedFerno-Washington Inc6
2011-09-29VAIVoluntary action indicatedFerno-Washington Inc6
2011-09-29VAIVoluntary action indicatedFerno-Washington Inc6
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