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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.

57 linked reportsMalfunction 53Injury 4
24672019-01: 0 reports for this device; peer average 4.54/device2019-02: 0 reports for this device; peer average 2.28/device2019-03: 0 reports for this device; peer average 2.88/device2019-04: 0 reports for this device; peer average 3.17/device2019-05: 0 reports for this device; peer average 3.26/device2019-06: 0 reports for this device; peer average 2.84/device2019-07: 0 reports for this device; peer average 3.71/device2019-08: 0 reports for this device; peer average 3.4/device2019-09: 1 reports for this device; peer average 3.25/device2019-10: 2 reports for this device; peer average 3.03/device2019-11: 2 reports for this device; peer average 5.09/device2019-12: 1 reports for this device; peer average 5.12/device2020-01: 1 reports for this device; peer average 4.9/device2020-02: 0 reports for this device; peer average 4.26/device2020-03: 2 reports for this device; peer average 3.9/device2020-04: 0 reports for this device; peer average 5.13/device2020-05: 0 reports for this device; peer average 3.88/device2020-06: 0 reports for this device; peer average 3.61/device2020-07: 0 reports for this device; peer average 3.69/device2020-08: 5 reports for this device; peer average 4.02/device2020-09: 0 reports for this device; peer average 3.97/device2020-10: 0 reports for this device; peer average 4.43/device2020-11: 0 reports for this device; peer average 6.31/device2020-12: 1 reports for this device; peer average 5.09/device2021-01: 1 reports for this device; peer average 4.59/device2021-02: 1 reports for this device; peer average 3.92/device2021-03: 0 reports for this device; peer average 3.76/device2021-04: 3 reports for this device; peer average 3.76/device2021-05: 2 reports for this device; peer average 3.97/device2021-06: 0 reports for this device; peer average 4.09/device2021-07: 0 reports for this device; peer average 3.91/device2021-08: 3 reports for this device; peer average 4.34/device2021-09: 0 reports for this device; peer average 3.99/device2021-10: 2 reports for this device; peer average 4.26/device2021-11: 0 reports for this device; peer average 4.32/device2021-12: 4 reports for this device; peer average 4.35/device2022-01: 3 reports for this device; peer average 3.99/device2022-02: 2 reports for this device; peer average 3.26/device2022-03: 0 reports for this device; peer average 3.86/device2022-04: 1 reports for this device; peer average 3.75/device2022-05: 0 reports for this device; peer average 4.65/device2022-06: 0 reports for this device; peer average 3.77/device2022-07: 0 reports for this device; peer average 3.54/device2022-08: 0 reports for this device; peer average 4.35/device2022-09: 0 reports for this device; peer average 3.78/device2022-10: 1 reports for this device; peer average 4.43/device2022-11: 1 reports for this device; peer average 2.88/device2022-12: 1 reports for this device; peer average 4.52/device2023-01: 1 reports for this device; peer average 3.22/device2023-02: 1 reports for this device; peer average 3.17/device2023-03: 0 reports for this device; peer average 4.23/device2023-04: 0 reports for this device; peer average 4.26/device2023-05: 0 reports for this device; peer average 4.59/device2023-06: 3 reports for this device; peer average 4.16/device2023-07: 0 reports for this device; peer average 3.81/device2023-08: 0 reports for this device; peer average 4.42/device2023-09: 0 reports for this device; peer average 4.41/device2023-10: 0 reports for this device; peer average 4.46/device2023-11: 0 reports for this device; peer average 4.54/device2023-12: 0 reports for this device; peer average 5.43/device2024-01: 0 reports for this device; peer average 5.55/device2024-02: 1 reports for this device; peer average 4.89/device2024-03: 0 reports for this device; peer average 4.69/device2024-04: 0 reports for this device; peer average 5.3/device2024-05: 0 reports for this device; peer average 6.41/device2024-06: 1 reports for this device; peer average 7.44/device2024-07: 0 reports for this device; peer average 4.08/device2024-08: 0 reports for this device; peer average 4.13/device2024-09: 1 reports for this device; peer average 4.96/device2024-10: 0 reports for this device; peer average 4.52/device2024-11: 1 reports for this device; peer average 4.23/device2024-12: 0 reports for this device; peer average 4.23/device2025-01: 0 reports for this device; peer average 4.98/device2025-02: 1 reports for this device; peer average 4.74/device2025-03: 0 reports for this device; peer average 4.57/device2025-04: 0 reports for this device; peer average 4.92/device2025-05: 0 reports for this device; peer average 5.72/device2025-06: 1 reports for this device; peer average 5.42/device2025-07: 1 reports for this device; peer average 5.09/device2025-08: 0 reports for this device; peer average 5.01/device2025-09: 0 reports for this device; peer average 4.28/device2025-10: 0 reports for this device; peer average 4.6/device2025-11: 3 reports for this device; peer average 5.13/device2025-12: 1 reports for this device; peer average 5.99/device2026-01: 0 reports for this device; peer average 5.03/device2026-02: 0 reports for this device; peer average 5.29/device2026-03: 1 reports for this device; peer average 5.9/device2026-04: 0 reports for this device; peer average 5.75/device2026-05: 0 reports for this device; peer average 5.77/device2026-06: 0 reports for this device; peer average 6.06/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.54
2019-0202.28
2019-0302.88
2019-0403.17
2019-0503.26
2019-0602.84
2019-0703.71
2019-0803.4
2019-0913.25
2019-1023.03
2019-1125.09
2019-1215.12
2020-0114.9
2020-0204.26
2020-0323.9
2020-0405.13
2020-0503.88
2020-0603.61
2020-0703.69
2020-0854.02
2020-0903.97
2020-1004.43
2020-1106.31
2020-1215.09
2021-0114.59
2021-0213.92
2021-0303.76
2021-0433.76
2021-0523.97
2021-0604.09
2021-0703.91
2021-0834.34
2021-0903.99
2021-1024.26
2021-1104.32
2021-1244.35
2022-0133.99
2022-0223.26
2022-0303.86
2022-0413.75
2022-0504.65
2022-0603.77
2022-0703.54
2022-0804.35
2022-0903.78
2022-1014.43
2022-1112.88
2022-1214.52
2023-0113.22
2023-0213.17
2023-0304.23
2023-0404.26
2023-0504.59
2023-0634.16
2023-0703.81
2023-0804.42
2023-0904.41
2023-1004.46
2023-1104.54
2023-1205.43
2024-0105.55
2024-0214.89
2024-0304.69
2024-0405.3
2024-0506.41
2024-0617.44
2024-0704.08
2024-0804.13
2024-0914.96
2024-1004.52
2024-1114.23
2024-1204.23
2025-0104.98
2025-0214.74
2025-0304.57
2025-0404.92
2025-0505.72
2025-0615.42
2025-0715.09
2025-0805.01
2025-0904.28
2025-1004.6
2025-1135.13
2025-1215.99
2026-0105.03
2026-0205.29
2026-0315.9
2026-0405.75
2026-0505.77
2026-0606.06
This device (reports/month)Average device in DZL, MBI (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
2026-03-030001825034-2026-00483InjuryAvailableexact di
2025-12-030001825034-2025-03864MalfunctionAvailableexact di
2025-11-190001825034-2025-03698MalfunctionAvailableexact di
2025-11-130001825034-2025-03608MalfunctionAvailableexact di
2025-11-040001825034-2025-03447MalfunctionAvailableexact di
2025-07-230001825034-2025-02208MalfunctionAvailableexact di
2025-06-030001825034-2025-01568MalfunctionAvailableexact di
2025-02-030001825034-2025-00246MalfunctionAvailableexact di
2024-11-270001825034-2024-02794MalfunctionAvailableexact di
2024-09-040001825034-2024-02147MalfunctionAvailableexact di
2024-06-060001825034-2024-01496MalfunctionAvailableexact di
2024-02-220001825034-2024-00493MalfunctionAvailableexact di
2023-06-270001825034-2023-01432MalfunctionAvailableexact di
2023-06-270001825034-2023-01433MalfunctionAvailableexact di
2023-06-120001825034-2023-01304MalfunctionAvailableexact di
Showing 1–15 of 57
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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