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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.

53 linked reportsMalfunction 40Injury 13
24682019-01: 0 reports for this device; peer average 4.67/device2019-02: 0 reports for this device; peer average 2.34/device2019-03: 0 reports for this device; peer average 3.13/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 2.82/device2019-07: 0 reports for this device; peer average 3.81/device2019-08: 0 reports for this device; peer average 3.49/device2019-09: 0 reports for this device; peer average 3.35/device2019-10: 0 reports for this device; peer average 3.19/device2019-11: 0 reports for this device; peer average 5.28/device2019-12: 0 reports for this device; peer average 5.45/device2020-01: 1 reports for this device; peer average 5.46/device2020-02: 0 reports for this device; peer average 4.5/device2020-03: 3 reports for this device; peer average 3.98/device2020-04: 0 reports for this device; peer average 5.42/device2020-05: 0 reports for this device; peer average 3.88/device2020-06: 0 reports for this device; peer average 3.71/device2020-07: 0 reports for this device; peer average 3.74/device2020-08: 0 reports for this device; peer average 4.23/device2020-09: 0 reports for this device; peer average 4.05/device2020-10: 1 reports for this device; peer average 4.53/device2020-11: 0 reports for this device; peer average 6.39/device2020-12: 0 reports for this device; peer average 5.41/device2021-01: 0 reports for this device; peer average 4.74/device2021-02: 0 reports for this device; peer average 3.95/device2021-03: 0 reports for this device; peer average 3.83/device2021-04: 2 reports for this device; peer average 3.82/device2021-05: 1 reports for this device; peer average 4.06/device2021-06: 1 reports for this device; peer average 4.11/device2021-07: 0 reports for this device; peer average 4/device2021-08: 2 reports for this device; peer average 4.46/device2021-09: 0 reports for this device; peer average 4.05/device2021-10: 0 reports for this device; peer average 4.44/device2021-11: 2 reports for this device; peer average 4.37/device2021-12: 0 reports for this device; peer average 4.43/device2022-01: 0 reports for this device; peer average 4/device2022-02: 3 reports for this device; peer average 3.37/device2022-03: 2 reports for this device; peer average 3.88/device2022-04: 0 reports for this device; peer average 3.8/device2022-05: 2 reports for this device; peer average 4.06/device2022-06: 1 reports for this device; peer average 3.85/device2022-07: 0 reports for this device; peer average 3.56/device2022-08: 1 reports for this device; peer average 4.39/device2022-09: 0 reports for this device; peer average 3.86/device2022-10: 5 reports for this device; peer average 4.15/device2022-11: 1 reports for this device; peer average 2.87/device2022-12: 1 reports for this device; peer average 3.93/device2023-01: 0 reports for this device; peer average 3.27/device2023-02: 0 reports for this device; peer average 3.2/device2023-03: 0 reports for this device; peer average 3.8/device2023-04: 0 reports for this device; peer average 4.26/device2023-05: 0 reports for this device; peer average 4.67/device2023-06: 1 reports for this device; peer average 4.2/device2023-07: 1 reports for this device; peer average 3.85/device2023-08: 1 reports for this device; peer average 4.49/device2023-09: 0 reports for this device; peer average 4.47/device2023-10: 2 reports for this device; peer average 4.71/device2023-11: 0 reports for this device; peer average 4.63/device2023-12: 0 reports for this device; peer average 5.49/device2024-01: 0 reports for this device; peer average 5.56/device2024-02: 0 reports for this device; peer average 4.93/device2024-03: 1 reports for this device; peer average 4.78/device2024-04: 0 reports for this device; peer average 5.43/device2024-05: 0 reports for this device; peer average 6.48/device2024-06: 3 reports for this device; peer average 7.52/device2024-07: 2 reports for this device; peer average 4.11/device2024-08: 1 reports for this device; peer average 4.21/device2024-09: 0 reports for this device; peer average 5/device2024-10: 0 reports for this device; peer average 4.7/device2024-11: 0 reports for this device; peer average 4.41/device2024-12: 0 reports for this device; peer average 4.25/device2025-01: 0 reports for this device; peer average 5.12/device2025-02: 1 reports for this device; peer average 4.81/device2025-03: 2 reports for this device; peer average 4.57/device2025-04: 0 reports for this device; peer average 4.98/device2025-05: 0 reports for this device; peer average 5.81/device2025-06: 0 reports for this device; peer average 5.47/device2025-07: 0 reports for this device; peer average 5.19/device2025-08: 0 reports for this device; peer average 5.08/device2025-09: 1 reports for this device; peer average 4.29/device2025-10: 1 reports for this device; peer average 4.62/device2025-11: 0 reports for this device; peer average 5.25/device2025-12: 1 reports for this device; peer average 6.07/device2026-01: 1 reports for this device; peer average 5.06/device2026-02: 0 reports for this device; peer average 5.39/device2026-03: 1 reports for this device; peer average 5.98/device2026-04: 0 reports for this device; peer average 5.93/device2026-05: 3 reports for this device; peer average 5.88/device2026-06: 1 reports for this device; peer average 6.16/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.67
2019-0202.34
2019-0303.13
2019-0403.17
2019-0503.26
2019-0602.82
2019-0703.81
2019-0803.49
2019-0903.35
2019-1003.19
2019-1105.28
2019-1205.45
2020-0115.46
2020-0204.5
2020-0333.98
2020-0405.42
2020-0503.88
2020-0603.71
2020-0703.74
2020-0804.23
2020-0904.05
2020-1014.53
2020-1106.39
2020-1205.41
2021-0104.74
2021-0203.95
2021-0303.83
2021-0423.82
2021-0514.06
2021-0614.11
2021-0704
2021-0824.46
2021-0904.05
2021-1004.44
2021-1124.37
2021-1204.43
2022-0104
2022-0233.37
2022-0323.88
2022-0403.8
2022-0524.06
2022-0613.85
2022-0703.56
2022-0814.39
2022-0903.86
2022-1054.15
2022-1112.87
2022-1213.93
2023-0103.27
2023-0203.2
2023-0303.8
2023-0404.26
2023-0504.67
2023-0614.2
2023-0713.85
2023-0814.49
2023-0904.47
2023-1024.71
2023-1104.63
2023-1205.49
2024-0105.56
2024-0204.93
2024-0314.78
2024-0405.43
2024-0506.48
2024-0637.52
2024-0724.11
2024-0814.21
2024-0905
2024-1004.7
2024-1104.41
2024-1204.25
2025-0105.12
2025-0214.81
2025-0324.57
2025-0404.98
2025-0505.81
2025-0605.47
2025-0705.19
2025-0805.08
2025-0914.29
2025-1014.62
2025-1105.25
2025-1216.07
2026-0115.06
2026-0205.39
2026-0315.98
2026-0405.93
2026-0535.88
2026-0616.16
This device (reports/month)Average device in 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
2026-06-080001825034-2026-01653InjuryAvailableexact di
2026-05-220001825034-2026-01453MalfunctionAvailableexact di
2026-05-210001825034-2026-01427MalfunctionAvailableexact di
2026-05-050001825034-2026-01202MalfunctionAvailableexact di
2026-03-200001825034-2026-00669InjuryAvailableexact di
2026-01-060001825034-2026-00056MalfunctionAvailableexact di
2025-12-040001825034-2025-03870MalfunctionAvailableexact di
2025-10-300001825034-2025-03412MalfunctionAvailableexact di
2025-09-110001825034-2025-02894MalfunctionAvailableexact di
2025-03-280001825034-2025-00865MalfunctionAvailableexact di
2025-03-140001825034-2025-00715MalfunctionAvailableexact di
2025-02-270001825034-2025-00496MalfunctionAvailableexact di
2024-08-260001825034-2024-02079InjuryAvailableexact di
2024-07-030001825034-2024-01772MalfunctionAvailableexact di
2024-07-030001825034-2024-01771InjuryAvailableexact di
Showing 1–15 of 53
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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