Skip to content
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.

100 linked reportsMalfunction 100
4811152019-01: 2 reports for this device; peer average 13.41/device2019-02: 0 reports for this device; peer average 3.29/device2019-03: 5 reports for this device; peer average 3.78/device2019-04: 9 reports for this device; peer average 4.27/device2019-05: 3 reports for this device; peer average 4.18/device2019-06: 4 reports for this device; peer average 3.67/device2019-07: 3 reports for this device; peer average 3.38/device2019-08: 6 reports for this device; peer average 3.9/device2019-09: 0 reports for this device; peer average 4.55/device2019-10: 0 reports for this device; peer average 5.02/device2019-11: 3 reports for this device; peer average 4.63/device2019-12: 5 reports for this device; peer average 5.21/device2020-01: 0 reports for this device; peer average 5.18/device2020-02: 15 reports for this device; peer average 5.84/device2020-03: 9 reports for this device; peer average 5.61/device2020-04: 4 reports for this device; peer average 5/device2020-05: 1 reports for this device; peer average 3.51/device2020-06: 0 reports for this device; peer average 5.69/device2020-07: 0 reports for this device; peer average 6.15/device2020-08: 0 reports for this device; peer average 5.71/device2020-09: 0 reports for this device; peer average 7.49/device2020-10: 0 reports for this device; peer average 8.72/device2020-11: 0 reports for this device; peer average 5.95/device2020-12: 4 reports for this device; peer average 8.86/device2021-01: 1 reports for this device; peer average 6.31/device2021-02: 1 reports for this device; peer average 5.77/device2021-03: 2 reports for this device; peer average 7.8/device2021-04: 3 reports for this device; peer average 6.1/device2021-05: 0 reports for this device; peer average 5.63/device2021-06: 0 reports for this device; peer average 5.7/device2021-07: 1 reports for this device; peer average 4.96/device2021-08: 2 reports for this device; peer average 5.25/device2021-09: 6 reports for this device; peer average 3.47/device2021-10: 1 reports for this device; peer average 5.1/device2021-11: 1 reports for this device; peer average 3.78/device2021-12: 1 reports for this device; peer average 5.41/device2022-01: 1 reports for this device; peer average 4.97/device2022-02: 0 reports for this device; peer average 3.74/device2022-03: 4 reports for this device; peer average 4.39/device2022-04: 1 reports for this device; peer average 4.17/device2022-05: 0 reports for this device; peer average 4.13/device2022-06: 0 reports for this device; peer average 4.35/device2022-07: 0 reports for this device; peer average 4.38/device2022-08: 0 reports for this device; peer average 4.33/device2022-09: 0 reports for this device; peer average 4.16/device2022-10: 0 reports for this device; peer average 4.1/device2022-11: 0 reports for this device; peer average 4.7/device2022-12: 0 reports for this device; peer average 4.67/device2023-01: 0 reports for this device; peer average 5.09/device2023-02: 0 reports for this device; peer average 4.36/device2023-03: 0 reports for this device; peer average 5.24/device2023-04: 0 reports for this device; peer average 4.82/device2023-05: 1 reports for this device; peer average 4.84/device2023-06: 0 reports for this device; peer average 4.5/device2023-07: 0 reports for this device; peer average 4.29/device2023-08: 0 reports for this device; peer average 5.05/device2023-09: 0 reports for this device; peer average 4.83/device2023-10: 0 reports for this device; peer average 4.41/device2023-11: 0 reports for this device; peer average 7.93/device2023-12: 0 reports for this device; peer average 8.8/device2024-01: 0 reports for this device; peer average 6.2/device2024-02: 0 reports for this device; peer average 6.57/device2024-03: 0 reports for this device; peer average 5.26/device2024-04: 0 reports for this device; peer average 5.97/device2024-05: 0 reports for this device; peer average 8.82/device2024-06: 0 reports for this device; peer average 8.82/device2024-07: 0 reports for this device; peer average 4.91/device2024-08: 0 reports for this device; peer average 4.86/device2024-09: 0 reports for this device; peer average 4.76/device2024-10: 1 reports for this device; peer average 6.15/device2024-11: 0 reports for this device; peer average 5.22/device2024-12: 0 reports for this device; peer average 7.58/device2025-01: 0 reports for this device; peer average 8.91/device2025-02: 0 reports for this device; peer average 6.11/device2025-03: 0 reports for this device; peer average 5.08/device2025-04: 0 reports for this device; peer average 5.43/device2025-05: 0 reports for this device; peer average 5.98/device2025-06: 0 reports for this device; peer average 5.09/device2025-07: 0 reports for this device; peer average 5.28/device2025-08: 0 reports for this device; peer average 4.37/device2025-09: 0 reports for this device; peer average 4.58/device2025-10: 0 reports for this device; peer average 5.09/device2025-11: 0 reports for this device; peer average 5.68/device2025-12: 0 reports for this device; peer average 5.94/device2026-01: 0 reports for this device; peer average 5.53/device2026-02: 0 reports for this device; peer average 5.56/device2026-03: 0 reports for this device; peer average 5.59/device2026-04: 0 reports for this device; peer average 7/device2026-05: 0 reports for this device; peer average 4.7/device2026-06: 0 reports for this device; peer average 4.85/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01213.41
2019-0203.29
2019-0353.78
2019-0494.27
2019-0534.18
2019-0643.67
2019-0733.38
2019-0863.9
2019-0904.55
2019-1005.02
2019-1134.63
2019-1255.21
2020-0105.18
2020-02155.84
2020-0395.61
2020-0445
2020-0513.51
2020-0605.69
2020-0706.15
2020-0805.71
2020-0907.49
2020-1008.72
2020-1105.95
2020-1248.86
2021-0116.31
2021-0215.77
2021-0327.8
2021-0436.1
2021-0505.63
2021-0605.7
2021-0714.96
2021-0825.25
2021-0963.47
2021-1015.1
2021-1113.78
2021-1215.41
2022-0114.97
2022-0203.74
2022-0344.39
2022-0414.17
2022-0504.13
2022-0604.35
2022-0704.38
2022-0804.33
2022-0904.16
2022-1004.1
2022-1104.7
2022-1204.67
2023-0105.09
2023-0204.36
2023-0305.24
2023-0404.82
2023-0514.84
2023-0604.5
2023-0704.29
2023-0805.05
2023-0904.83
2023-1004.41
2023-1107.93
2023-1208.8
2024-0106.2
2024-0206.57
2024-0305.26
2024-0405.97
2024-0508.82
2024-0608.82
2024-0704.91
2024-0804.86
2024-0904.76
2024-1016.15
2024-1105.22
2024-1207.58
2025-0108.91
2025-0206.11
2025-0305.08
2025-0405.43
2025-0505.98
2025-0605.09
2025-0705.28
2025-0804.37
2025-0904.58
2025-1005.09
2025-1105.68
2025-1205.94
2026-0105.53
2026-0205.56
2026-0305.59
2026-0407
2026-0504.7
2026-0604.85
This device (reports/month)Average device in HRX (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
2024-10-221221934-2024-03783MalfunctionAvailableexact di
2023-05-301221934-2023-02187MalfunctionAvailableexact di
2022-04-261221934-2022-01215MalfunctionAvailableexact di
2022-03-231221934-2022-00893MalfunctionAvailableexact di
2022-03-031221934-2022-00717MalfunctionAvailablecatalog number
2022-01-241221934-2022-00270MalfunctionAvailableexact di
2021-12-021221934-2021-03574MalfunctionAvailableexact di
2021-11-301221934-2021-03496MalfunctionAvailableexact di
2021-10-051221934-2021-02880MalfunctionAvailableexact di
2021-09-241221934-2021-02791MalfunctionAvailableexact di
2021-09-241221934-2021-02792MalfunctionAvailableexact di
2021-09-241221934-2021-02793MalfunctionAvailableexact di
2021-09-241221934-2021-02790MalfunctionAvailablecatalog number
2021-08-121221934-2021-02465MalfunctionAvailableexact di
2021-08-021221934-2021-02348MalfunctionAvailableexact di

Showing the most recent 59 of 100 linked reports.

Showing 1–15 of 59
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

Similar devices
Select up to two to place side-by-side with this device.