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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.

1,313 linked reportsMalfunction 1,300Injury 13
1012033044052020-11: 4 reports for this device; peer average 4/device2020-12: 19 reports for this device; peer average 10/device2021-01: 14 reports for this device; peer average 10.5/device2021-02: 4 reports for this device; peer average 6/device2021-03: 17 reports for this device; peer average 7/device2021-04: 192 reports for this device; peer average 97/device2021-05: 2 reports for this device; peer average 2.33/device2021-06: 4 reports for this device; peer average 2/device2021-07: 9 reports for this device; peer average 5/device2021-08: 11 reports for this device; peer average 6.25/device2021-09: 27 reports for this device; peer average 13.6/device2021-10: 8 reports for this device; peer average 14.67/device2021-11: 16 reports for this device; peer average 14.25/device2021-12: 59 reports for this device; peer average 40.86/device2022-01: 6 reports for this device; peer average 160.6/device2022-02: 15 reports for this device; peer average 262.88/device2022-03: 12 reports for this device; peer average 247.75/device2022-04: 258 reports for this device; peer average 236.6/device2022-05: 54 reports for this device; peer average 153/device2022-06: 80 reports for this device; peer average 266.25/device2022-07: 23 reports for this device; peer average 74.5/device2022-08: 133 reports for this device; peer average 174.67/device2022-09: 16 reports for this device; peer average 271.33/device2022-10: 190 reports for this device; peer average 220/device2022-11: 5 reports for this device; peer average 102/device2022-12: 21 reports for this device; peer average 183.5/device2023-01: 8 reports for this device; peer average 93.2/device2023-02: 10 reports for this device; peer average 405/device2023-03: 0 reports for this device; peer average 185.67/device2023-04: 10 reports for this device; peer average 98.33/device2023-05: 3 reports for this device; peer average 239/device2023-06: 4 reports for this device; peer average 29/device2023-07: 5 reports for this device; peer average 54/device2023-08: 1 reports for this device; peer average 22.25/device2023-09: 7 reports for this device; peer average 23/device2023-10: 2 reports for this device; peer average 7.75/device2023-11: 0 reports for this device; peer average 15/device2023-12: 5 reports for this device; peer average 6.67/device2024-01: 7 reports for this device; peer average 11.8/device2024-02: 16 reports for this device; peer average 5.75/device2024-03: 13 reports for this device; peer average 8.67/device2024-04: 0 reports for this device; peer average 4.67/device2024-05: 0 reports for this device; peer average 3/device2024-06: 3 reports for this device; peer average 4/device2024-07: 2 reports for this device; peer average 3.67/device2024-08: 0 reports for this device; peer average 10.5/device2024-09: 0 reports for this device; peer average 17/device2024-10: 1 reports for this device; peer average 9.8/device2024-11: 2 reports for this device; peer average 8.2/device2024-12: 0 reports for this device; peer average 2.33/device2025-01: 0 reports for this device; peer average 18.33/device2025-02: 0 reports for this device; peer average 23/device2025-03: 10 reports for this device; peer average 10/device2025-05: 0 reports for this device; peer average 17/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 28/device2025-09: 0 reports for this device; peer average 11/device2025-12: 0 reports for this device; peer average 2/device2026-04: 1 reports for this device; peer average 1/device2026-05: 4 reports for this device; peer average 4/device11120102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030506070809120405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-1144
2020-121910
2021-011410.5
2021-0246
2021-03177
2021-0419297
2021-0522.33
2021-0642
2021-0795
2021-08116.25
2021-092713.6
2021-10814.67
2021-111614.25
2021-125940.86
2022-016160.6
2022-0215262.88
2022-0312247.75
2022-04258236.6
2022-0554153
2022-0680266.25
2022-072374.5
2022-08133174.67
2022-0916271.33
2022-10190220
2022-115102
2022-1221183.5
2023-01893.2
2023-0210405
2023-030185.67
2023-041098.33
2023-053239
2023-06429
2023-07554
2023-08122.25
2023-09723
2023-1027.75
2023-11015
2023-1256.67
2024-01711.8
2024-02165.75
2024-03138.67
2024-0404.67
2024-0503
2024-0634
2024-0723.67
2024-08010.5
2024-09017
2024-1019.8
2024-1128.2
2024-1202.33
2025-01018.33
2025-02023
2025-031010
2025-05017
2025-0601
2025-0701
2025-08028
2025-09011
2025-1202
2026-0411
2026-0544
This device (reports/month)Average device in QKP (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-05-141221359-2026-00166MalfunctionAvailableexact di
2026-05-141221359-2026-00165MalfunctionAvailableexact di
2026-05-141221359-2026-00167MalfunctionAvailableexact di
2026-05-141221359-2026-00168MalfunctionAvailableexact di
2026-04-271221359-2026-00060MalfunctionAvailableexact di
2025-03-211221359-2025-00112MalfunctionAvailableexact di
2025-03-211221359-2025-00113MalfunctionAvailableexact di
2025-03-211221359-2025-00117MalfunctionAvailableexact di
2025-03-211221359-2025-00114MalfunctionAvailableexact di
2025-03-211221359-2025-00118MalfunctionAvailableexact di
2025-03-211221359-2025-00111MalfunctionAvailableexact di
2025-03-211221359-2025-00116MalfunctionAvailableexact di
2025-03-211221359-2025-00110MalfunctionAvailableexact di
2025-03-211221359-2025-00115MalfunctionAvailableexact di
2025-03-211221359-2025-00109MalfunctionAvailableexact di

Showing the most recent 200 of 1,313 linked reports.

Showing 1–15 of 200
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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