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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 14Injury 13
1012033044052020-11: 0 reports for this device; peer average 4/device2020-12: 0 reports for this device; peer average 10/device2021-01: 0 reports for this device; peer average 10.5/device2021-02: 0 reports for this device; peer average 6/device2021-03: 1 reports for this device; peer average 7/device2021-04: 0 reports for this device; peer average 97/device2021-05: 0 reports for this device; peer average 2.33/device2021-06: 1 reports for this device; peer average 2/device2021-07: 1 reports for this device; peer average 5/device2021-08: 0 reports for this device; peer average 6.25/device2021-09: 3 reports for this device; peer average 13.6/device2021-10: 1 reports for this device; peer average 14.67/device2021-11: 1 reports for this device; peer average 14.25/device2021-12: 2 reports for this device; peer average 40.86/device2022-01: 2 reports for this device; peer average 160.6/device2022-02: 1 reports for this device; peer average 262.88/device2022-03: 0 reports for this device; peer average 247.75/device2022-04: 2 reports for this device; peer average 236.6/device2022-05: 5 reports for this device; peer average 153/device2022-06: 0 reports for this device; peer average 266.25/device2022-07: 4 reports for this device; peer average 74.5/device2022-08: 1 reports for this device; peer average 174.67/device2022-09: 0 reports for this device; peer average 271.33/device2022-10: 0 reports for this device; peer average 220/device2022-11: 0 reports for this device; peer average 102/device2022-12: 0 reports for this device; peer average 183.5/device2023-01: 0 reports for this device; peer average 93.2/device2023-02: 0 reports for this device; peer average 405/device2023-03: 0 reports for this device; peer average 185.67/device2023-04: 0 reports for this device; peer average 98.33/device2023-05: 0 reports for this device; peer average 239/device2023-06: 2 reports for this device; peer average 29/device2023-07: 0 reports for this device; peer average 54/device2023-08: 0 reports for this device; peer average 22.25/device2023-09: 0 reports for this device; peer average 23/device2023-10: 0 reports for this device; peer average 7.75/device2023-11: 0 reports for this device; peer average 15/device2023-12: 0 reports for this device; peer average 6.67/device2024-01: 0 reports for this device; peer average 11.8/device2024-02: 0 reports for this device; peer average 5.75/device2024-03: 0 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: 0 reports for this device; peer average 4/device2024-07: 0 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: 0 reports for this device; peer average 9.8/device2024-11: 0 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: 0 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: 0 reports for this device; peer average 1/device2026-05: 0 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)
2020-1104
2020-12010
2021-01010.5
2021-0206
2021-0317
2021-04097
2021-0502.33
2021-0612
2021-0715
2021-0806.25
2021-09313.6
2021-10114.67
2021-11114.25
2021-12240.86
2022-012160.6
2022-021262.88
2022-030247.75
2022-042236.6
2022-055153
2022-060266.25
2022-07474.5
2022-081174.67
2022-090271.33
2022-100220
2022-110102
2022-120183.5
2023-01093.2
2023-020405
2023-030185.67
2023-04098.33
2023-050239
2023-06229
2023-07054
2023-08022.25
2023-09023
2023-1007.75
2023-11015
2023-1206.67
2024-01011.8
2024-0205.75
2024-0308.67
2024-0404.67
2024-0503
2024-0604
2024-0703.67
2024-08010.5
2024-09017
2024-1009.8
2024-1108.2
2024-1202.33
2025-01018.33
2025-02023
2025-03010
2025-05017
2025-0601
2025-0701
2025-08028
2025-09011
2025-1202
2026-0401
2026-0504
This device (reports/month)Average device in QKP (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
2023-06-071221359-2023-01197MalfunctionAvailableexact di
2023-06-071221359-2023-01198MalfunctionAvailableexact di
2022-08-241221359-2022-04298InjuryAvailableexact di
2022-07-211221359-2022-03624InjuryAvailableexact di
2022-07-131221359-2022-03420MalfunctionAvailableexact di
2022-07-131221359-2022-03421MalfunctionAvailableexact di
2022-07-131221359-2022-03440MalfunctionAvailableexact di
2022-05-311221359-2022-02820InjuryAvailableexact di
2022-05-111221359-2022-02188InjuryAvailableexact di
2022-05-071221359-2022-02304InjuryAvailableexact di
2022-05-041221359-2022-02399InjuryAvailableexact di
2022-05-041221359-2022-02173MalfunctionAvailableexact di
2022-04-281221359-2022-02179InjuryAvailableexact di
2022-04-221221359-2022-02118InjuryAvailableexact di
2022-02-021221359-2022-00621MalfunctionAvailableexact di
Showing 1–15 of 27
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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