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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.

109 linked reportsMalfunction 99Injury 10
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: 0 reports for this device; peer average 3.03/device2019-11: 4 reports for this device; peer average 5.09/device2019-12: 0 reports for this device; peer average 5.12/device2020-01: 2 reports for this device; peer average 4.9/device2020-02: 3 reports for this device; peer average 4.26/device2020-03: 1 reports for this device; peer average 3.9/device2020-04: 4 reports for this device; peer average 5.13/device2020-05: 0 reports for this device; peer average 3.88/device2020-06: 1 reports for this device; peer average 3.61/device2020-07: 1 reports for this device; peer average 3.69/device2020-08: 5 reports for this device; peer average 4.02/device2020-09: 1 reports for this device; peer average 3.97/device2020-10: 1 reports for this device; peer average 4.43/device2020-11: 1 reports for this device; peer average 6.31/device2020-12: 1 reports for this device; peer average 5.09/device2021-01: 7 reports for this device; peer average 4.59/device2021-02: 4 reports for this device; peer average 3.92/device2021-03: 2 reports for this device; peer average 3.76/device2021-04: 3 reports for this device; peer average 3.76/device2021-05: 0 reports for this device; peer average 3.97/device2021-06: 3 reports for this device; peer average 4.09/device2021-07: 1 reports for this device; peer average 3.91/device2021-08: 0 reports for this device; peer average 4.34/device2021-09: 2 reports for this device; peer average 3.99/device2021-10: 0 reports for this device; peer average 4.26/device2021-11: 1 reports for this device; peer average 4.32/device2021-12: 3 reports for this device; peer average 4.35/device2022-01: 0 reports for this device; peer average 3.99/device2022-02: 2 reports for this device; peer average 3.26/device2022-03: 2 reports for this device; peer average 3.86/device2022-04: 4 reports for this device; peer average 3.75/device2022-05: 0 reports for this device; peer average 4.65/device2022-06: 1 reports for this device; peer average 3.77/device2022-07: 0 reports for this device; peer average 3.54/device2022-08: 3 reports for this device; peer average 4.35/device2022-09: 2 reports for this device; peer average 3.78/device2022-10: 2 reports for this device; peer average 4.43/device2022-11: 1 reports for this device; peer average 2.88/device2022-12: 2 reports for this device; peer average 4.52/device2023-01: 1 reports for this device; peer average 3.22/device2023-02: 3 reports for this device; peer average 3.17/device2023-03: 5 reports for this device; peer average 4.23/device2023-04: 0 reports for this device; peer average 4.26/device2023-05: 3 reports for this device; peer average 4.59/device2023-06: 0 reports for this device; peer average 4.16/device2023-07: 1 reports for this device; peer average 3.81/device2023-08: 1 reports for this device; peer average 4.42/device2023-09: 0 reports for this device; peer average 4.41/device2023-10: 1 reports for this device; peer average 4.46/device2023-11: 1 reports for this device; peer average 4.54/device2023-12: 2 reports for this device; peer average 5.43/device2024-01: 0 reports for this device; peer average 5.55/device2024-02: 0 reports for this device; peer average 4.89/device2024-03: 2 reports for this device; peer average 4.69/device2024-04: 2 reports for this device; peer average 5.3/device2024-05: 0 reports for this device; peer average 6.41/device2024-06: 0 reports for this device; peer average 7.44/device2024-07: 4 reports for this device; peer average 4.08/device2024-08: 1 reports for this device; peer average 4.13/device2024-09: 1 reports for this device; peer average 4.96/device2024-10: 2 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: 0 reports for this device; peer average 5.42/device2025-07: 1 reports for this device; peer average 5.09/device2025-08: 1 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: 0 reports for this device; peer average 5.13/device2025-12: 0 reports for this device; peer average 5.99/device2026-01: 0 reports for this device; peer average 5.03/device2026-02: 1 reports for this device; peer average 5.29/device2026-03: 1 reports for this device; peer average 5.9/device2026-04: 1 reports for this device; peer average 5.75/device2026-05: 1 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
2019-1003.03
2019-1145.09
2019-1205.12
2020-0124.9
2020-0234.26
2020-0313.9
2020-0445.13
2020-0503.88
2020-0613.61
2020-0713.69
2020-0854.02
2020-0913.97
2020-1014.43
2020-1116.31
2020-1215.09
2021-0174.59
2021-0243.92
2021-0323.76
2021-0433.76
2021-0503.97
2021-0634.09
2021-0713.91
2021-0804.34
2021-0923.99
2021-1004.26
2021-1114.32
2021-1234.35
2022-0103.99
2022-0223.26
2022-0323.86
2022-0443.75
2022-0504.65
2022-0613.77
2022-0703.54
2022-0834.35
2022-0923.78
2022-1024.43
2022-1112.88
2022-1224.52
2023-0113.22
2023-0233.17
2023-0354.23
2023-0404.26
2023-0534.59
2023-0604.16
2023-0713.81
2023-0814.42
2023-0904.41
2023-1014.46
2023-1114.54
2023-1225.43
2024-0105.55
2024-0204.89
2024-0324.69
2024-0425.3
2024-0506.41
2024-0607.44
2024-0744.08
2024-0814.13
2024-0914.96
2024-1024.52
2024-1114.23
2024-1204.23
2025-0104.98
2025-0214.74
2025-0304.57
2025-0404.92
2025-0505.72
2025-0605.42
2025-0715.09
2025-0815.01
2025-0904.28
2025-1004.6
2025-1105.13
2025-1205.99
2026-0105.03
2026-0215.29
2026-0315.9
2026-0415.75
2026-0515.77
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
2026-05-080001825034-2026-01239MalfunctionAvailableexact di
2026-04-010001825034-2026-00800MalfunctionAvailableexact di
2026-03-190001825034-2026-00665MalfunctionAvailableexact di
2026-02-020001825034-2026-00260InjuryAvailableexact di
2025-08-260001825034-2025-02690MalfunctionAvailableexact di
2025-07-300001825034-2025-02314MalfunctionAvailableexact di
2025-02-240001825034-2025-00429MalfunctionAvailableexact di
2024-11-270001825034-2024-02791InjuryAvailableexact di
2024-10-230001825034-2024-02500MalfunctionAvailableexact di
2024-10-170001825034-2024-02463MalfunctionAvailableexact di
2024-09-260001825034-2024-02276MalfunctionAvailableexact di
2024-08-220001825034-2024-02067MalfunctionAvailableexact di
2024-07-160001825034-2024-01845InjuryAvailableexact di
2024-07-160001825034-2024-01844InjuryAvailableexact di
2024-07-020001825034-2024-01744MalfunctionAvailableexact di
Showing 1–15 of 109
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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