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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.

55 linked reportsMalfunction 54Injury 1
12232019-01: 0 reports for this device; peer average 3.16/device2019-02: 0 reports for this device; peer average 2.68/device2019-03: 0 reports for this device; peer average 3.02/device2019-04: 0 reports for this device; peer average 2.82/device2019-05: 0 reports for this device; peer average 2.23/device2019-06: 0 reports for this device; peer average 1.89/device2019-07: 0 reports for this device; peer average 1.92/device2019-08: 0 reports for this device; peer average 2.17/device2019-09: 0 reports for this device; peer average 2.47/device2019-10: 0 reports for this device; peer average 2.67/device2019-11: 0 reports for this device; peer average 2.2/device2019-12: 0 reports for this device; peer average 2.56/device2020-01: 0 reports for this device; peer average 2.89/device2020-02: 0 reports for this device; peer average 2.62/device2020-03: 0 reports for this device; peer average 3.31/device2020-04: 0 reports for this device; peer average 2.27/device2020-05: 0 reports for this device; peer average 2.31/device2020-06: 0 reports for this device; peer average 2.06/device2020-07: 0 reports for this device; peer average 2.51/device2020-08: 0 reports for this device; peer average 2.04/device2020-09: 0 reports for this device; peer average 2.61/device2020-10: 0 reports for this device; peer average 2.6/device2020-11: 0 reports for this device; peer average 2.38/device2020-12: 0 reports for this device; peer average 2.38/device2021-01: 0 reports for this device; peer average 2.51/device2021-02: 0 reports for this device; peer average 2.06/device2021-03: 1 reports for this device; peer average 2.1/device2021-04: 0 reports for this device; peer average 2.06/device2021-05: 0 reports for this device; peer average 2.04/device2021-06: 2 reports for this device; peer average 2.51/device2021-07: 1 reports for this device; peer average 2.37/device2021-08: 0 reports for this device; peer average 2.28/device2021-09: 0 reports for this device; peer average 2.42/device2021-10: 1 reports for this device; peer average 2.2/device2021-11: 0 reports for this device; peer average 2.12/device2021-12: 2 reports for this device; peer average 2.33/device2022-01: 0 reports for this device; peer average 2.09/device2022-02: 1 reports for this device; peer average 2.04/device2022-03: 1 reports for this device; peer average 2.17/device2022-04: 0 reports for this device; peer average 2.15/device2022-05: 0 reports for this device; peer average 2.12/device2022-06: 0 reports for this device; peer average 2.23/device2022-07: 1 reports for this device; peer average 2.12/device2022-08: 2 reports for this device; peer average 2.12/device2022-09: 0 reports for this device; peer average 2.12/device2022-10: 1 reports for this device; peer average 2.13/device2022-11: 3 reports for this device; peer average 2.2/device2022-12: 0 reports for this device; peer average 2.21/device2023-01: 0 reports for this device; peer average 2.15/device2023-02: 2 reports for this device; peer average 2.04/device2023-03: 1 reports for this device; peer average 2.33/device2023-04: 0 reports for this device; peer average 2.22/device2023-05: 0 reports for this device; peer average 2.12/device2023-06: 0 reports for this device; peer average 2.16/device2023-07: 1 reports for this device; peer average 2.04/device2023-08: 0 reports for this device; peer average 1.91/device2023-09: 0 reports for this device; peer average 1.88/device2023-10: 2 reports for this device; peer average 1.62/device2023-11: 1 reports for this device; peer average 1.61/device2023-12: 1 reports for this device; peer average 1.69/device2024-01: 1 reports for this device; peer average 1.74/device2024-02: 0 reports for this device; peer average 1.98/device2024-03: 3 reports for this device; peer average 1.9/device2024-04: 0 reports for this device; peer average 1.74/device2024-05: 2 reports for this device; peer average 1.99/device2024-06: 2 reports for this device; peer average 1.85/device2024-07: 3 reports for this device; peer average 1.73/device2024-08: 1 reports for this device; peer average 1.81/device2024-09: 1 reports for this device; peer average 1.93/device2024-10: 3 reports for this device; peer average 1.72/device2024-11: 2 reports for this device; peer average 1.73/device2024-12: 0 reports for this device; peer average 1.53/device2025-01: 0 reports for this device; peer average 1.87/device2025-02: 0 reports for this device; peer average 1.49/device2025-03: 1 reports for this device; peer average 1.72/device2025-04: 1 reports for this device; peer average 1.77/device2025-05: 1 reports for this device; peer average 1.69/device2025-06: 0 reports for this device; peer average 1.8/device2025-07: 0 reports for this device; peer average 1.76/device2025-08: 1 reports for this device; peer average 1.65/device2025-09: 0 reports for this device; peer average 1.72/device2025-10: 0 reports for this device; peer average 1.71/device2025-11: 1 reports for this device; peer average 1.77/device2025-12: 1 reports for this device; peer average 1.89/device2026-01: 2 reports for this device; peer average 1.91/device2026-02: 2 reports for this device; peer average 1.61/device2026-03: 1 reports for this device; peer average 1.91/device2026-04: 0 reports for this device; peer average 1.9/device2026-05: 2 reports for this device; peer average 1.7/device2026-06: 0 reports for this device; peer average 1.7/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.16
2019-0202.68
2019-0303.02
2019-0402.82
2019-0502.23
2019-0601.89
2019-0701.92
2019-0802.17
2019-0902.47
2019-1002.67
2019-1102.2
2019-1202.56
2020-0102.89
2020-0202.62
2020-0303.31
2020-0402.27
2020-0502.31
2020-0602.06
2020-0702.51
2020-0802.04
2020-0902.61
2020-1002.6
2020-1102.38
2020-1202.38
2021-0102.51
2021-0202.06
2021-0312.1
2021-0402.06
2021-0502.04
2021-0622.51
2021-0712.37
2021-0802.28
2021-0902.42
2021-1012.2
2021-1102.12
2021-1222.33
2022-0102.09
2022-0212.04
2022-0312.17
2022-0402.15
2022-0502.12
2022-0602.23
2022-0712.12
2022-0822.12
2022-0902.12
2022-1012.13
2022-1132.2
2022-1202.21
2023-0102.15
2023-0222.04
2023-0312.33
2023-0402.22
2023-0502.12
2023-0602.16
2023-0712.04
2023-0801.91
2023-0901.88
2023-1021.62
2023-1111.61
2023-1211.69
2024-0111.74
2024-0201.98
2024-0331.9
2024-0401.74
2024-0521.99
2024-0621.85
2024-0731.73
2024-0811.81
2024-0911.93
2024-1031.72
2024-1121.73
2024-1201.53
2025-0101.87
2025-0201.49
2025-0311.72
2025-0411.77
2025-0511.69
2025-0601.8
2025-0701.76
2025-0811.65
2025-0901.72
2025-1001.71
2025-1111.77
2025-1211.89
2026-0121.91
2026-0221.61
2026-0311.91
2026-0401.9
2026-0521.7
2026-0601.7
This device (reports/month)Average device in JDI, KWZ, LPH, LZO, OQG, OQH, OQI, PBI (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
2026-05-270001825034-2026-01466MalfunctionAvailableexact di
2026-05-110001825034-2026-01252MalfunctionAvailableexact di
2026-03-110001825034-2026-00559MalfunctionAvailableexact di
2026-02-230001825034-2026-00435MalfunctionAvailableexact di
2026-02-040001825034-2026-00287MalfunctionAvailableexact di
2026-01-220001825034-2026-00193MalfunctionAvailableexact di
2026-01-200001825034-2026-00171MalfunctionAvailableexact di
2025-12-110001825034-2025-03961MalfunctionAvailableexact di
2025-11-070001825034-2025-03535MalfunctionAvailableexact di
2025-08-110001825034-2025-02416MalfunctionAvailableexact di
2025-05-160001825034-2025-01437MalfunctionAvailableexact di
2025-04-210001825034-2025-01152InjuryAvailableexact di
2025-03-260001825034-2025-00844MalfunctionAvailableexact di
2024-11-250001825034-2024-02773MalfunctionAvailableexact di
2024-11-130001825034-2024-02675MalfunctionAvailableexact di
Showing 1–15 of 55
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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