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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.

86 linked reportsMalfunction 69Injury 17
101929382019-01: 0 reports for this device; peer average 12.29/device2019-02: 0 reports for this device; peer average 14.11/device2019-03: 0 reports for this device; peer average 13.79/device2019-04: 0 reports for this device; peer average 17.85/device2019-05: 0 reports for this device; peer average 19.37/device2019-06: 0 reports for this device; peer average 19.72/device2019-07: 0 reports for this device; peer average 13.34/device2019-08: 0 reports for this device; peer average 11.84/device2019-09: 1 reports for this device; peer average 11.76/device2019-10: 0 reports for this device; peer average 9.56/device2019-11: 0 reports for this device; peer average 11.77/device2019-12: 0 reports for this device; peer average 14.42/device2020-01: 0 reports for this device; peer average 10.77/device2020-02: 38 reports for this device; peer average 12.09/device2020-03: 0 reports for this device; peer average 12.63/device2020-04: 0 reports for this device; peer average 10.79/device2020-05: 0 reports for this device; peer average 14.51/device2020-06: 0 reports for this device; peer average 11.22/device2020-07: 0 reports for this device; peer average 13.17/device2020-08: 0 reports for this device; peer average 11.68/device2020-09: 0 reports for this device; peer average 10.81/device2020-10: 0 reports for this device; peer average 11.91/device2020-11: 0 reports for this device; peer average 12.95/device2020-12: 0 reports for this device; peer average 11.79/device2021-01: 0 reports for this device; peer average 11.04/device2021-02: 0 reports for this device; peer average 12.98/device2021-03: 0 reports for this device; peer average 12.28/device2021-04: 0 reports for this device; peer average 12.01/device2021-05: 0 reports for this device; peer average 13.69/device2021-06: 3 reports for this device; peer average 16.07/device2021-07: 1 reports for this device; peer average 12.52/device2021-08: 3 reports for this device; peer average 14.63/device2021-09: 1 reports for this device; peer average 21.27/device2021-10: 1 reports for this device; peer average 12.6/device2021-11: 0 reports for this device; peer average 14.61/device2021-12: 0 reports for this device; peer average 11.69/device2022-01: 1 reports for this device; peer average 9.82/device2022-02: 5 reports for this device; peer average 11.02/device2022-03: 2 reports for this device; peer average 13.31/device2022-04: 1 reports for this device; peer average 10.99/device2022-05: 1 reports for this device; peer average 14.33/device2022-06: 0 reports for this device; peer average 13.79/device2022-07: 0 reports for this device; peer average 11.32/device2022-08: 2 reports for this device; peer average 12.48/device2022-09: 1 reports for this device; peer average 13.86/device2022-10: 0 reports for this device; peer average 16.25/device2022-11: 0 reports for this device; peer average 14.37/device2022-12: 0 reports for this device; peer average 13.48/device2023-01: 1 reports for this device; peer average 12.02/device2023-02: 0 reports for this device; peer average 11.05/device2023-03: 0 reports for this device; peer average 14.05/device2023-04: 1 reports for this device; peer average 11.93/device2023-05: 0 reports for this device; peer average 13.92/device2023-06: 0 reports for this device; peer average 20.13/device2023-07: 0 reports for this device; peer average 20.36/device2023-08: 0 reports for this device; peer average 19.05/device2023-09: 0 reports for this device; peer average 13.77/device2023-10: 0 reports for this device; peer average 15.56/device2023-11: 0 reports for this device; peer average 15.33/device2023-12: 0 reports for this device; peer average 16.27/device2024-01: 0 reports for this device; peer average 22.02/device2024-02: 0 reports for this device; peer average 17.25/device2024-03: 1 reports for this device; peer average 17.66/device2024-04: 0 reports for this device; peer average 18.36/device2024-05: 2 reports for this device; peer average 14.83/device2024-06: 0 reports for this device; peer average 14.7/device2024-07: 0 reports for this device; peer average 19.11/device2024-08: 1 reports for this device; peer average 25.11/device2024-09: 0 reports for this device; peer average 19.41/device2024-10: 0 reports for this device; peer average 23.57/device2024-11: 0 reports for this device; peer average 13.03/device2024-12: 0 reports for this device; peer average 14.59/device2025-01: 0 reports for this device; peer average 14.46/device2025-02: 18 reports for this device; peer average 19.62/device2025-03: 1 reports for this device; peer average 18.89/device2025-04: 0 reports for this device; peer average 19.25/device2025-05: 0 reports for this device; peer average 16.53/device2025-06: 0 reports for this device; peer average 25.12/device2025-07: 0 reports for this device; peer average 15.88/device2025-08: 0 reports for this device; peer average 14.53/device2025-09: 0 reports for this device; peer average 15.12/device2025-10: 0 reports for this device; peer average 15.97/device2025-11: 0 reports for this device; peer average 13.1/device2025-12: 0 reports for this device; peer average 12.77/device2026-01: 0 reports for this device; peer average 14.05/device2026-02: 0 reports for this device; peer average 11.14/device2026-03: 0 reports for this device; peer average 15.44/device2026-04: 0 reports for this device; peer average 11.76/device2026-05: 0 reports for this device; peer average 13.89/device2026-06: 0 reports for this device; peer average 9.32/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01012.29
2019-02014.11
2019-03013.79
2019-04017.85
2019-05019.37
2019-06019.72
2019-07013.34
2019-08011.84
2019-09111.76
2019-1009.56
2019-11011.77
2019-12014.42
2020-01010.77
2020-023812.09
2020-03012.63
2020-04010.79
2020-05014.51
2020-06011.22
2020-07013.17
2020-08011.68
2020-09010.81
2020-10011.91
2020-11012.95
2020-12011.79
2021-01011.04
2021-02012.98
2021-03012.28
2021-04012.01
2021-05013.69
2021-06316.07
2021-07112.52
2021-08314.63
2021-09121.27
2021-10112.6
2021-11014.61
2021-12011.69
2022-0119.82
2022-02511.02
2022-03213.31
2022-04110.99
2022-05114.33
2022-06013.79
2022-07011.32
2022-08212.48
2022-09113.86
2022-10016.25
2022-11014.37
2022-12013.48
2023-01112.02
2023-02011.05
2023-03014.05
2023-04111.93
2023-05013.92
2023-06020.13
2023-07020.36
2023-08019.05
2023-09013.77
2023-10015.56
2023-11015.33
2023-12016.27
2024-01022.02
2024-02017.25
2024-03117.66
2024-04018.36
2024-05214.83
2024-06014.7
2024-07019.11
2024-08125.11
2024-09019.41
2024-10023.57
2024-11013.03
2024-12014.59
2025-01014.46
2025-021819.62
2025-03118.89
2025-04019.25
2025-05016.53
2025-06025.12
2025-07015.88
2025-08014.53
2025-09015.12
2025-10015.97
2025-11013.1
2025-12012.77
2026-01014.05
2026-02011.14
2026-03015.44
2026-04011.76
2026-05013.89
2026-0609.32
This device (reports/month)Average device in HAW, LLZ (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
2025-03-243005075696-2025-00234MalfunctionAvailableprocode brand trgm
2025-02-243005075696-2025-00220MalfunctionAvailableexact di
2025-02-243005075696-2025-00221MalfunctionAvailableexact di
2025-02-243005075696-2025-00223MalfunctionAvailableexact di
2025-02-243005075696-2025-00222MalfunctionAvailableexact di
2025-02-243005075696-2025-00224MalfunctionAvailableexact di
2025-02-193005075696-2025-00217MalfunctionAvailableprocode brand trgm
2025-02-193005075696-2025-00215MalfunctionAvailableprocode brand trgm
2025-02-193005075696-2025-00211MalfunctionAvailableexact di
2025-02-193005075696-2025-00214MalfunctionAvailableprocode brand trgm
2025-02-193005075696-2025-00212MalfunctionAvailableprocode brand trgm
2025-02-193005075696-2025-00209MalfunctionAvailableexact di
2024-08-083005075696-2024-00104InjuryAvailableprocode brand trgm
2024-05-223005075696-2024-00060InjuryAvailableprocode brand trgm
2024-05-163005075696-2024-00059InjuryAvailableprocode brand trgm

Showing the most recent 76 of 86 linked reports.

Showing 1–15 of 76
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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