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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.

405 linked reportsMalfunction 350Injury 52Death 3
112334452019-01: 0 reports for this device; peer average 2.41/device2019-02: 0 reports for this device; peer average 1.71/device2019-03: 0 reports for this device; peer average 3/device2019-04: 2 reports for this device; peer average 2.46/device2019-05: 0 reports for this device; peer average 1.89/device2019-06: 0 reports for this device; peer average 2.33/device2019-07: 0 reports for this device; peer average 2.48/device2019-08: 3 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 2.59/device2019-11: 3 reports for this device; peer average 1.8/device2019-12: 0 reports for this device; peer average 2.5/device2020-01: 0 reports for this device; peer average 2.8/device2020-02: 0 reports for this device; peer average 2.5/device2020-03: 0 reports for this device; peer average 1.17/device2020-04: 0 reports for this device; peer average 3/device2020-05: 7 reports for this device; peer average 2.8/device2020-06: 2 reports for this device; peer average 1.67/device2020-07: 0 reports for this device; peer average 2.92/device2020-08: 0 reports for this device; peer average 1.15/device2020-09: 3 reports for this device; peer average 1.5/device2020-10: 5 reports for this device; peer average 2.92/device2020-11: 0 reports for this device; peer average 2.25/device2020-12: 0 reports for this device; peer average 1/device2021-01: 3 reports for this device; peer average 4.96/device2021-02: 0 reports for this device; peer average 3.35/device2021-03: 0 reports for this device; peer average 1.67/device2021-04: 0 reports for this device; peer average 2.43/device2021-05: 3 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 1.89/device2021-07: 0 reports for this device; peer average 2.47/device2021-08: 0 reports for this device; peer average 1.6/device2021-09: 0 reports for this device; peer average 1.2/device2021-10: 0 reports for this device; peer average 2.83/device2021-11: 0 reports for this device; peer average 1.17/device2021-12: 0 reports for this device; peer average 1.67/device2022-01: 3 reports for this device; peer average 2.72/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1.75/device2022-04: 0 reports for this device; peer average 3.1/device2022-05: 0 reports for this device; peer average 2.33/device2022-06: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 3.23/device2022-08: 3 reports for this device; peer average 1.75/device2022-09: 9 reports for this device; peer average 4/device2022-10: 0 reports for this device; peer average 3.29/device2022-11: 0 reports for this device; peer average 1.43/device2022-12: 3 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 3.16/device2023-02: 0 reports for this device; peer average 1.67/device2023-03: 6 reports for this device; peer average 2.3/device2023-04: 6 reports for this device; peer average 3.68/device2023-05: 6 reports for this device; peer average 2.33/device2023-06: 3 reports for this device; peer average 2.4/device2023-07: 20 reports for this device; peer average 3.68/device2023-08: 0 reports for this device; peer average 1.63/device2023-09: 3 reports for this device; peer average 1.77/device2023-10: 0 reports for this device; peer average 3.5/device2023-11: 0 reports for this device; peer average 2.5/device2023-12: 0 reports for this device; peer average 2.4/device2024-01: 4 reports for this device; peer average 3.57/device2024-02: 14 reports for this device; peer average 3.17/device2024-03: 0 reports for this device; peer average 1.71/device2024-04: 45 reports for this device; peer average 4.21/device2024-05: 3 reports for this device; peer average 1.43/device2024-06: 9 reports for this device; peer average 2.3/device2024-07: 15 reports for this device; peer average 3.51/device2024-08: 5 reports for this device; peer average 1.57/device2024-09: 24 reports for this device; peer average 7/device2024-10: 11 reports for this device; peer average 4/device2024-11: 18 reports for this device; peer average 5.43/device2024-12: 2 reports for this device; peer average 4.6/device2025-01: 8 reports for this device; peer average 3.77/device2025-02: 19 reports for this device; peer average 6.67/device2025-03: 35 reports for this device; peer average 8/device2025-04: 8 reports for this device; peer average 3.81/device2025-05: 9 reports for this device; peer average 6/device2025-06: 2 reports for this device; peer average 3/device2025-07: 10 reports for this device; peer average 3.23/device2025-08: 12 reports for this device; peer average 5.67/device2025-09: 8 reports for this device; peer average 5/device2025-10: 7 reports for this device; peer average 3.47/device2025-11: 12 reports for this device; peer average 5.67/device2025-12: 6 reports for this device; peer average 3.22/device2026-01: 8 reports for this device; peer average 3.13/device2026-02: 6 reports for this device; peer average 4.67/device2026-03: 3 reports for this device; peer average 5.11/device2026-04: 6 reports for this device; peer average 3.84/device2026-05: 0 reports for this device; peer average 10.43/device2026-06: 3 reports for this device; peer average 7.43/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.41
2019-0201.71
2019-0303
2019-0422.46
2019-0501.89
2019-0602.33
2019-0702.48
2019-0832
2019-0901
2019-1002.59
2019-1131.8
2019-1202.5
2020-0102.8
2020-0202.5
2020-0301.17
2020-0403
2020-0572.8
2020-0621.67
2020-0702.92
2020-0801.15
2020-0931.5
2020-1052.92
2020-1102.25
2020-1201
2021-0134.96
2021-0203.35
2021-0301.67
2021-0402.43
2021-0532
2021-0601.89
2021-0702.47
2021-0801.6
2021-0901.2
2021-1002.83
2021-1101.17
2021-1201.67
2022-0132.72
2022-0201
2022-0301.75
2022-0403.1
2022-0502.33
2022-0601
2022-0703.23
2022-0831.75
2022-0994
2022-1003.29
2022-1101.43
2022-1232
2023-0103.16
2023-0201.67
2023-0362.3
2023-0463.68
2023-0562.33
2023-0632.4
2023-07203.68
2023-0801.63
2023-0931.77
2023-1003.5
2023-1102.5
2023-1202.4
2024-0143.57
2024-02143.17
2024-0301.71
2024-04454.21
2024-0531.43
2024-0692.3
2024-07153.51
2024-0851.57
2024-09247
2024-10114
2024-11185.43
2024-1224.6
2025-0183.77
2025-02196.67
2025-03358
2025-0483.81
2025-0596
2025-0623
2025-07103.23
2025-08125.67
2025-0985
2025-1073.47
2025-11125.67
2025-1263.22
2026-0183.13
2026-0264.67
2026-0335.11
2026-0463.84
2026-05010.43
2026-0637.43
This device (reports/month)Average device in FPO (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
2026-06-301523574-2026-00068Malfunctionexact di
2026-04-091523574-2026-00031MalfunctionAvailableexact di
2026-04-011523574-2026-00027MalfunctionAvailableexact di
2026-03-091523574-2026-00024MalfunctionAvailableexact di
2026-02-181523574-2026-00020MalfunctionAvailableexact di
2026-02-181523574-2026-00019MalfunctionAvailableexact di
2026-01-231523574-2026-00013MalfunctionAvailableexact di
2026-01-231523574-2026-00006InjuryAvailableexact di
2026-01-061523574-2026-00007InjuryAvailablemodel number
2025-12-101523574-2025-00111MalfunctionAvailableexact di
2025-12-011523574-2025-00109MalfunctionAvailableexact di
2025-11-181523574-2025-00105MalfunctionAvailableexact di
2025-11-111523574-2025-00103MalfunctionAvailableexact di
2025-11-111523574-2025-00107MalfunctionAvailableexact di
2025-11-061523574-2025-00102MalfunctionAvailableexact di

Showing the most recent 143 of 405 linked reports.

Showing 115 of 143
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2023-01-24VAIVoluntary action indicatedFerno-Washington Inc6
2023-01-24VAIVoluntary action indicatedFerno-Washington Inc6
2018-07-23NAINo action indicatedFerno-Washington Inc0
2018-07-23NAINo action indicatedFerno-Washington Inc0
2015-03-11VAIVoluntary action indicatedFerno-Washington Inc6
2015-03-11VAIVoluntary action indicatedFerno-Washington Inc6
2011-09-29VAIVoluntary action indicatedFerno-Washington Inc6
2011-09-29VAIVoluntary action indicatedFerno-Washington Inc6