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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.

5 linked reportsMalfunction 4Death 1
91726342019-01: 0 reports for this device; peer average 2/device2019-02: 0 reports for this device; peer average 4/device2019-03: 0 reports for this device; peer average 3/device2019-04: 0 reports for this device; peer average 6.5/device2019-05: 2 reports for this device; peer average 2.33/device2019-06: 0 reports for this device; peer average 4.25/device2019-07: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 4/device2019-10: 0 reports for this device; peer average 2.4/device2019-11: 0 reports for this device; peer average 2/device2019-12: 0 reports for this device; peer average 1.8/device2020-01: 0 reports for this device; peer average 1.5/device2020-02: 0 reports for this device; peer average 1.5/device2020-03: 0 reports for this device; peer average 2.33/device2020-04: 0 reports for this device; peer average 2/device2020-05: 0 reports for this device; peer average 1.33/device2020-07: 0 reports for this device; peer average 2/device2020-08: 0 reports for this device; peer average 1.67/device2020-09: 0 reports for this device; peer average 1.5/device2020-10: 0 reports for this device; peer average 2.2/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 7/device2021-03: 0 reports for this device; peer average 6.67/device2021-04: 0 reports for this device; peer average 3/device2021-05: 0 reports for this device; peer average 2.5/device2021-06: 0 reports for this device; peer average 12.25/device2021-07: 0 reports for this device; peer average 22.5/device2021-08: 0 reports for this device; peer average 16.5/device2021-09: 0 reports for this device; peer average 8.5/device2021-10: 0 reports for this device; peer average 30/device2021-11: 0 reports for this device; peer average 22/device2021-12: 0 reports for this device; peer average 11.75/device2022-01: 0 reports for this device; peer average 12.67/device2022-02: 0 reports for this device; peer average 9/device2022-03: 0 reports for this device; peer average 34/device2022-04: 0 reports for this device; peer average 3.25/device2022-05: 0 reports for this device; peer average 3/device2022-06: 0 reports for this device; peer average 1.67/device2022-07: 0 reports for this device; peer average 3/device2022-08: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 4/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 2.67/device2023-03: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 2.33/device2023-06: 0 reports for this device; peer average 2.5/device2023-07: 0 reports for this device; peer average 3/device2023-08: 1 reports for this device; peer average 1.67/device2023-09: 0 reports for this device; peer average 2.75/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 3/device2023-12: 0 reports for this device; peer average 2.33/device2024-01: 0 reports for this device; peer average 3.5/device2024-02: 0 reports for this device; peer average 3.5/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 3.25/device2024-05: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 2.33/device2024-07: 0 reports for this device; peer average 3.5/device2024-08: 0 reports for this device; peer average 1.67/device2024-09: 2 reports for this device; peer average 1.5/device2024-10: 0 reports for this device; peer average 5/device2024-11: 0 reports for this device; peer average 6.67/device2024-12: 0 reports for this device; peer average 4/device2025-01: 0 reports for this device; peer average 1.6/device2025-02: 0 reports for this device; peer average 3.5/device2025-03: 0 reports for this device; peer average 3/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 3/device2025-06: 0 reports for this device; peer average 1.8/device2025-07: 0 reports for this device; peer average 5/device2025-09: 0 reports for this device; peer average 1.5/device2025-10: 0 reports for this device; peer average 2.83/device2025-11: 0 reports for this device; peer average 3/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 2.5/device2026-03: 0 reports for this device; peer average 3.2/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 1.25/device2026-06: 0 reports for this device; peer average 3.83/device0102030405060708091011120102030405070809101112020304050607080910111201020304050607080910111202030405060708091011120102030405060708091011120102030405060709101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0204
2019-0303
2019-0406.5
2019-0522.33
2019-0604.25
2019-0702
2019-0802
2019-0904
2019-1002.4
2019-1102
2019-1201.8
2020-0101.5
2020-0201.5
2020-0302.33
2020-0402
2020-0501.33
2020-0702
2020-0801.67
2020-0901.5
2020-1002.2
2020-1101
2020-1202
2021-0207
2021-0306.67
2021-0403
2021-0502.5
2021-06012.25
2021-07022.5
2021-08016.5
2021-0908.5
2021-10030
2021-11022
2021-12011.75
2022-01012.67
2022-0209
2022-03034
2022-0403.25
2022-0503
2022-0601.67
2022-0703
2022-0802
2022-0904
2022-1002
2022-1102
2022-1202
2023-0202.67
2023-0303
2023-0402
2023-0502.33
2023-0602.5
2023-0703
2023-0811.67
2023-0902.75
2023-1002
2023-1103
2023-1202.33
2024-0103.5
2024-0203.5
2024-0302
2024-0403.25
2024-0502
2024-0602.33
2024-0703.5
2024-0801.67
2024-0921.5
2024-1005
2024-1106.67
2024-1204
2025-0101.6
2025-0203.5
2025-0303
2025-0401
2025-0503
2025-0601.8
2025-0705
2025-0901.5
2025-1002.83
2025-1103
2025-1202
2026-0102
2026-0202.5
2026-0303.2
2026-0402
2026-0501.25
2026-0603.83
This device (reports/month)Average device in HIG (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2024-09-273002914049-2024-00004MalfunctionAvailableexact di
2023-08-183002914049-2023-00007DeathAvailableexact di
2019-05-133002914049-2019-00002MalfunctionAvailableexact di

Showing the most recent 3 of 5 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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