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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.

82 linked reportsInjury 82
2551761022019-01: 0 reports for this device; peer average 4.02/device2019-02: 0 reports for this device; peer average 5.49/device2019-03: 0 reports for this device; peer average 4.31/device2019-04: 0 reports for this device; peer average 4.35/device2019-05: 0 reports for this device; peer average 4.17/device2019-06: 0 reports for this device; peer average 7.53/device2019-07: 0 reports for this device; peer average 6.39/device2019-08: 0 reports for this device; peer average 5.67/device2019-09: 0 reports for this device; peer average 101.74/device2019-10: 0 reports for this device; peer average 19.81/device2019-11: 0 reports for this device; peer average 16.08/device2019-12: 0 reports for this device; peer average 30.69/device2020-01: 0 reports for this device; peer average 21.27/device2020-02: 0 reports for this device; peer average 20.62/device2020-03: 0 reports for this device; peer average 27.38/device2020-04: 0 reports for this device; peer average 11.97/device2020-05: 0 reports for this device; peer average 16.48/device2020-06: 0 reports for this device; peer average 19.79/device2020-07: 0 reports for this device; peer average 20.77/device2020-08: 0 reports for this device; peer average 21.31/device2020-09: 0 reports for this device; peer average 21.29/device2020-10: 0 reports for this device; peer average 24.87/device2020-11: 0 reports for this device; peer average 25.78/device2020-12: 0 reports for this device; peer average 23.76/device2021-01: 0 reports for this device; peer average 25.39/device2021-02: 0 reports for this device; peer average 23.01/device2021-03: 0 reports for this device; peer average 26.58/device2021-04: 0 reports for this device; peer average 27.25/device2021-05: 0 reports for this device; peer average 26.71/device2021-06: 0 reports for this device; peer average 25.72/device2021-07: 0 reports for this device; peer average 26.62/device2021-08: 2 reports for this device; peer average 25.87/device2021-09: 2 reports for this device; peer average 26.57/device2021-10: 0 reports for this device; peer average 13.4/device2021-11: 2 reports for this device; peer average 37.66/device2021-12: 0 reports for this device; peer average 40.89/device2022-01: 0 reports for this device; peer average 37.75/device2022-02: 0 reports for this device; peer average 34.42/device2022-03: 0 reports for this device; peer average 36.79/device2022-04: 0 reports for this device; peer average 35.22/device2022-05: 0 reports for this device; peer average 37.22/device2022-06: 4 reports for this device; peer average 36.79/device2022-07: 2 reports for this device; peer average 35.39/device2022-08: 2 reports for this device; peer average 37.6/device2022-09: 0 reports for this device; peer average 36.7/device2022-10: 2 reports for this device; peer average 42.21/device2022-11: 2 reports for this device; peer average 39.36/device2022-12: 0 reports for this device; peer average 41.85/device2023-01: 4 reports for this device; peer average 34.77/device2023-02: 2 reports for this device; peer average 35.66/device2023-03: 2 reports for this device; peer average 41.37/device2023-04: 2 reports for this device; peer average 38.17/device2023-05: 0 reports for this device; peer average 41.87/device2023-06: 6 reports for this device; peer average 45.96/device2023-07: 4 reports for this device; peer average 39.31/device2023-08: 1 reports for this device; peer average 33.01/device2023-09: 0 reports for this device; peer average 31.49/device2023-10: 1 reports for this device; peer average 33.43/device2023-11: 3 reports for this device; peer average 36.94/device2023-12: 0 reports for this device; peer average 34.53/device2024-01: 2 reports for this device; peer average 34.21/device2024-02: 1 reports for this device; peer average 34.57/device2024-03: 1 reports for this device; peer average 34.07/device2024-04: 2 reports for this device; peer average 37.37/device2024-05: 0 reports for this device; peer average 34.78/device2024-06: 2 reports for this device; peer average 33.12/device2024-07: 2 reports for this device; peer average 32.62/device2024-08: 5 reports for this device; peer average 31.39/device2024-09: 1 reports for this device; peer average 36.84/device2024-10: 2 reports for this device; peer average 36.67/device2024-11: 1 reports for this device; peer average 30.96/device2024-12: 3 reports for this device; peer average 26.15/device2025-01: 2 reports for this device; peer average 24.35/device2025-02: 1 reports for this device; peer average 23.19/device2025-03: 0 reports for this device; peer average 25.54/device2025-04: 1 reports for this device; peer average 14.63/device2025-05: 0 reports for this device; peer average 10.86/device2025-06: 1 reports for this device; peer average 51.12/device2025-07: 1 reports for this device; peer average 38.65/device2025-08: 1 reports for this device; peer average 31.25/device2025-09: 0 reports for this device; peer average 24.9/device2025-10: 2 reports for this device; peer average 23.31/device2025-11: 2 reports for this device; peer average 25.93/device2025-12: 0 reports for this device; peer average 29.86/device2026-01: 1 reports for this device; peer average 27.04/device2026-02: 2 reports for this device; peer average 27.07/device2026-03: 0 reports for this device; peer average 26.64/device2026-04: 3 reports for this device; peer average 25.99/device2026-05: 0 reports for this device; peer average 26.41/device2026-06: 0 reports for this device; peer average 27.45/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.02
2019-0205.49
2019-0304.31
2019-0404.35
2019-0504.17
2019-0607.53
2019-0706.39
2019-0805.67
2019-090101.74
2019-10019.81
2019-11016.08
2019-12030.69
2020-01021.27
2020-02020.62
2020-03027.38
2020-04011.97
2020-05016.48
2020-06019.79
2020-07020.77
2020-08021.31
2020-09021.29
2020-10024.87
2020-11025.78
2020-12023.76
2021-01025.39
2021-02023.01
2021-03026.58
2021-04027.25
2021-05026.71
2021-06025.72
2021-07026.62
2021-08225.87
2021-09226.57
2021-10013.4
2021-11237.66
2021-12040.89
2022-01037.75
2022-02034.42
2022-03036.79
2022-04035.22
2022-05037.22
2022-06436.79
2022-07235.39
2022-08237.6
2022-09036.7
2022-10242.21
2022-11239.36
2022-12041.85
2023-01434.77
2023-02235.66
2023-03241.37
2023-04238.17
2023-05041.87
2023-06645.96
2023-07439.31
2023-08133.01
2023-09031.49
2023-10133.43
2023-11336.94
2023-12034.53
2024-01234.21
2024-02134.57
2024-03134.07
2024-04237.37
2024-05034.78
2024-06233.12
2024-07232.62
2024-08531.39
2024-09136.84
2024-10236.67
2024-11130.96
2024-12326.15
2025-01224.35
2025-02123.19
2025-03025.54
2025-04114.63
2025-05010.86
2025-06151.12
2025-07138.65
2025-08131.25
2025-09024.9
2025-10223.31
2025-11225.93
2025-12029.86
2026-01127.04
2026-02227.07
2026-03026.64
2026-04325.99
2026-05026.41
2026-06027.45
This device (reports/month)Average device in DZE (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
2026-04-219613866-2026-52193InjuryAvailablemodel number
2026-04-219613866-2026-52348InjuryAvailablemodel number
2026-04-019613866-2026-50646InjuryAvailablemodel number
2026-02-059613866-2026-47054InjuryAvailablemodel number
2026-02-039613866-2026-47143InjuryAvailablemodel number
2026-01-209613866-2026-45717InjuryAvailablemodel number
2025-11-209613866-2025-41897InjuryAvailablemodel number
2025-11-209613866-2025-41896InjuryAvailablemodel number
2025-10-289613866-2025-40503InjuryAvailablemodel number
2025-10-079613866-2025-38922InjuryAvailablemodel number
2025-08-119613866-2025-36769InjuryAvailablemodel number
2025-07-089613866-2025-32967InjuryAvailablemodel number
2025-06-179613866-2025-31508InjuryAvailablemodel number
2025-04-239613866-2025-29496InjuryAvailablemodel number
2025-02-059613866-2025-24389InjuryAvailablemodel number

Showing the most recent 62 of 82 linked reports.

Showing 1–15 of 62
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2014-12-08VAIVoluntary action indicatedALTATEC GmbH3
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