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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.

17 linked reportsMalfunction 17
571141712292019-01: 0 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1.5/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 2.67/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1.5/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1.33/device2020-03: 0 reports for this device; peer average 7.67/device2020-04: 0 reports for this device; peer average 2/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1.8/device2020-07: 0 reports for this device; peer average 4/device2020-08: 0 reports for this device; peer average 2.5/device2020-09: 0 reports for this device; peer average 7.57/device2020-10: 0 reports for this device; peer average 6.13/device2020-11: 0 reports for this device; peer average 6.33/device2020-12: 4 reports for this device; peer average 20.45/device2021-01: 0 reports for this device; peer average 5.17/device2021-02: 2 reports for this device; peer average 4/device2021-03: 4 reports for this device; peer average 5.7/device2021-04: 0 reports for this device; peer average 15/device2021-05: 0 reports for this device; peer average 3/device2021-06: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 5.33/device2021-09: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 8/device2021-11: 2 reports for this device; peer average 3.8/device2021-12: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 4/device2022-02: 4 reports for this device; peer average 2.67/device2022-03: 0 reports for this device; peer average 4/device2022-04: 0 reports for this device; peer average 2.17/device2022-05: 0 reports for this device; peer average 2.25/device2022-06: 0 reports for this device; peer average 5.33/device2022-07: 0 reports for this device; peer average 3/device2022-08: 0 reports for this device; peer average 1.33/device2022-09: 0 reports for this device; peer average 30.33/device2022-10: 0 reports for this device; peer average 5/device2022-11: 0 reports for this device; peer average 4.33/device2023-01: 0 reports for this device; peer average 6/device2023-02: 0 reports for this device; peer average 2.25/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 2.67/device2023-05: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 5/device2023-07: 0 reports for this device; peer average 1.5/device2023-08: 0 reports for this device; peer average 4.4/device2023-09: 0 reports for this device; peer average 125/device2023-10: 0 reports for this device; peer average 194.75/device2023-11: 0 reports for this device; peer average 68/device2023-12: 0 reports for this device; peer average 10/device2024-01: 0 reports for this device; peer average 11.67/device2024-02: 0 reports for this device; peer average 37/device2024-04: 0 reports for this device; peer average 8/device2024-05: 0 reports for this device; peer average 3/device2024-06: 0 reports for this device; peer average 17.75/device2024-07: 0 reports for this device; peer average 100/device2024-08: 0 reports for this device; peer average 7.5/device2024-09: 0 reports for this device; peer average 144/device2024-10: 0 reports for this device; peer average 26.27/device2024-11: 0 reports for this device; peer average 6.75/device2024-12: 0 reports for this device; peer average 1.33/device2025-01: 0 reports for this device; peer average 65.83/device2025-02: 0 reports for this device; peer average 228.5/device2025-03: 0 reports for this device; peer average 23.75/device2025-04: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 21.18/device2025-06: 0 reports for this device; peer average 28.4/device2025-07: 0 reports for this device; peer average 15.67/device2025-08: 0 reports for this device; peer average 12.67/device2025-09: 0 reports for this device; peer average 49.14/device2025-10: 1 reports for this device; peer average 8.4/device2025-11: 0 reports for this device; peer average 69/device2025-12: 0 reports for this device; peer average 76.5/device2026-01: 0 reports for this device; peer average 53/device2026-02: 0 reports for this device; peer average 13.5/device2026-03: 0 reports for this device; peer average 10.4/device2026-04: 0 reports for this device; peer average 49.25/device2026-05: 0 reports for this device; peer average 11/device2026-06: 0 reports for this device; peer average 4/device0102030405060708091011010203040506070809101112010203040506080910111201020304050607080910110102030405060708091011120102040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0201.5
2019-0301
2019-0402
2019-0501
2019-0601
2019-0702
2019-0802.67
2019-0901
2019-1001
2019-1101.5
2020-0101
2020-0201.33
2020-0307.67
2020-0402
2020-0501
2020-0601.8
2020-0704
2020-0802.5
2020-0907.57
2020-1006.13
2020-1106.33
2020-12420.45
2021-0105.17
2021-0224
2021-0345.7
2021-04015
2021-0503
2021-0602
2021-0805.33
2021-0903
2021-1008
2021-1123.8
2021-1201
2022-0104
2022-0242.67
2022-0304
2022-0402.17
2022-0502.25
2022-0605.33
2022-0703
2022-0801.33
2022-09030.33
2022-1005
2022-1104.33
2023-0106
2023-0202.25
2023-0302
2023-0402.67
2023-0502
2023-0605
2023-0701.5
2023-0804.4
2023-090125
2023-100194.75
2023-11068
2023-12010
2024-01011.67
2024-02037
2024-0408
2024-0503
2024-06017.75
2024-070100
2024-0807.5
2024-090144
2024-10026.27
2024-1106.75
2024-1201.33
2025-01065.83
2025-020228.5
2025-03023.75
2025-0402
2025-05021.18
2025-06028.4
2025-07015.67
2025-08012.67
2025-09049.14
2025-1018.4
2025-11069
2025-12076.5
2026-01053
2026-02013.5
2026-03010.4
2026-04049.25
2026-05011
2026-0604
This device (reports/month)Average device in NAD (reports/device/month)
Failure-mode summaryAI-generated

17 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-10-108043484-2025-00094MalfunctionAvailableexact di
2022-02-098043484-2022-00063MalfunctionAvailableexact di
2022-02-098043484-2022-00064MalfunctionAvailableexact di
2021-11-308043484-2021-01986MalfunctionAvailableexact di
2021-03-078043484-2021-00508MalfunctionAvailableexact di
2021-03-078043484-2021-00505MalfunctionAvailableexact di
2021-02-038043484-2021-00260MalfunctionAvailableexact di
2020-12-108043484-2020-04162MalfunctionAvailableexact di
2020-12-038043484-2020-04045MalfunctionAvailableexact di

Showing the most recent 9 of 17 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2015-07-09VAIVoluntary action indicatedSmith & Nephew Medical, Ltd.3
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