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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.

99 linked reportsMalfunction 97Injury 2
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: 0 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: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 5/device2021-08: 0 reports for this device; peer average 6.25/device2021-09: 0 reports for this device; peer average 13.6/device2021-10: 0 reports for this device; peer average 14.67/device2021-11: 0 reports for this device; peer average 14.25/device2021-12: 0 reports for this device; peer average 40.86/device2022-01: 0 reports for this device; peer average 160.6/device2022-02: 0 reports for this device; peer average 262.88/device2022-03: 0 reports for this device; peer average 247.75/device2022-04: 0 reports for this device; peer average 236.6/device2022-05: 0 reports for this device; peer average 153/device2022-06: 0 reports for this device; peer average 266.25/device2022-07: 0 reports for this device; peer average 74.5/device2022-08: 0 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: 1 reports for this device; peer average 29/device2023-07: 0 reports for this device; peer average 54/device2023-08: 5 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: 18 reports for this device; peer average 15/device2023-12: 9 reports for this device; peer average 6.67/device2024-01: 10 reports for this device; peer average 11.8/device2024-02: 2 reports for this device; peer average 5.75/device2024-03: 2 reports for this device; peer average 8.67/device2024-04: 1 reports for this device; peer average 4.67/device2024-05: 0 reports for this device; peer average 3/device2024-06: 7 reports for this device; peer average 4/device2024-07: 0 reports for this device; peer average 3.67/device2024-08: 14 reports for this device; peer average 10.5/device2024-09: 16 reports for this device; peer average 17/device2024-10: 5 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
2021-0307
2021-04097
2021-0502.33
2021-0602
2021-0705
2021-0806.25
2021-09013.6
2021-10014.67
2021-11014.25
2021-12040.86
2022-010160.6
2022-020262.88
2022-030247.75
2022-040236.6
2022-050153
2022-060266.25
2022-07074.5
2022-080174.67
2022-090271.33
2022-100220
2022-110102
2022-120183.5
2023-01093.2
2023-020405
2023-030185.67
2023-04098.33
2023-050239
2023-06129
2023-07054
2023-08522.25
2023-09723
2023-1027.75
2023-111815
2023-1296.67
2024-011011.8
2024-0225.75
2024-0328.67
2024-0414.67
2024-0503
2024-0674
2024-0703.67
2024-081410.5
2024-091617
2024-1059.8
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

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2024-10-160002024674-2024-00444MalfunctionAvailableexact di
2024-10-160002024674-2024-00445MalfunctionAvailableexact di
2024-10-150002024674-2024-00514MalfunctionAvailableexact di
2024-10-150002024674-2024-00513MalfunctionAvailableexact di
2024-10-150002024674-2024-00515MalfunctionAvailableexact di
2024-09-250002024674-2024-00462MalfunctionAvailableexact di
2024-09-240002024674-2024-00461MalfunctionAvailableexact di
2024-09-190002024674-2024-00319MalfunctionAvailableexact di
2024-09-170002024674-2024-00474MalfunctionAvailableexact di
2024-09-170002024674-2024-00477MalfunctionAvailableexact di
2024-09-170002024674-2024-00476MalfunctionAvailableexact di
2024-09-170002024674-2024-00475MalfunctionAvailableexact di
2024-09-130002024674-2024-00460MalfunctionAvailableexact di
2024-09-100002024674-2024-00471MalfunctionAvailableexact di
2024-09-100002024674-2024-00470MalfunctionAvailableexact di
Showing 1–15 of 99
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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