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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.

1 linked reportInjury 1
12342019-01: 0 reports for this device; peer average 1.75/device2019-02: 0 reports for this device; peer average 1.17/device2019-03: 0 reports for this device; peer average 1.25/device2019-04: 0 reports for this device; peer average 2.14/device2019-05: 0 reports for this device; peer average 2.17/device2019-06: 0 reports for this device; peer average 3/device2019-07: 0 reports for this device; peer average 1.33/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 2.5/device2019-10: 0 reports for this device; peer average 1.33/device2019-11: 0 reports for this device; peer average 1.17/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 1.25/device2020-03: 0 reports for this device; peer average 2.33/device2020-04: 0 reports for this device; peer average 1.25/device2020-05: 0 reports for this device; peer average 1.67/device2020-06: 0 reports for this device; peer average 2.6/device2020-07: 0 reports for this device; peer average 2/device2020-08: 0 reports for this device; peer average 1.45/device2020-09: 0 reports for this device; peer average 2.5/device2020-10: 0 reports for this device; peer average 3.71/device2020-11: 0 reports for this device; peer average 2.36/device2020-12: 0 reports for this device; peer average 2.82/device2021-01: 0 reports for this device; peer average 2.44/device2021-02: 0 reports for this device; peer average 3.17/device2021-03: 0 reports for this device; peer average 3/device2021-04: 0 reports for this device; peer average 4.14/device2021-05: 0 reports for this device; peer average 4.25/device2021-06: 0 reports for this device; peer average 3.44/device2021-07: 0 reports for this device; peer average 1.75/device2021-08: 0 reports for this device; peer average 3.86/device2021-09: 0 reports for this device; peer average 3.44/device2021-10: 0 reports for this device; peer average 2.5/device2021-11: 0 reports for this device; peer average 2.2/device2021-12: 0 reports for this device; peer average 3.29/device2022-01: 0 reports for this device; peer average 3.67/device2022-02: 0 reports for this device; peer average 3.5/device2022-03: 0 reports for this device; peer average 2.14/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 2.25/device2022-07: 0 reports for this device; peer average 3/device2022-08: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 2.5/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 1.5/device2023-05: 0 reports for this device; peer average 3/device2023-06: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 3.5/device2023-08: 0 reports for this device; peer average 1.5/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1.5/device2023-11: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1.8/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1.5/device2024-07: 0 reports for this device; peer average 1.78/device2024-08: 0 reports for this device; peer average 3/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 1.6/device2024-12: 0 reports for this device; peer average 1.5/device2025-01: 0 reports for this device; peer average 1.33/device2025-02: 0 reports for this device; peer average 1/device2025-03: 1 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 1.8/device2025-05: 0 reports for this device; peer average 3.67/device2025-06: 0 reports for this device; peer average 1.5/device2025-07: 0 reports for this device; peer average 3/device2025-08: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1.6/device2025-10: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 1.25/device2025-12: 0 reports for this device; peer average 1.43/device2026-01: 0 reports for this device; peer average 1.6/device2026-02: 0 reports for this device; peer average 1.8/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1.43/device2026-05: 0 reports for this device; peer average 1.89/device2026-06: 0 reports for this device; peer average 3.06/device01020304050607080910111201020304050607080910111201020304050607080910111201020304050708111201020304050607080910110103040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.75
2019-0201.17
2019-0301.25
2019-0402.14
2019-0502.17
2019-0603
2019-0701.33
2019-0802
2019-0902.5
2019-1001.33
2019-1101.17
2019-1201
2020-0102
2020-0201.25
2020-0302.33
2020-0401.25
2020-0501.67
2020-0602.6
2020-0702
2020-0801.45
2020-0902.5
2020-1003.71
2020-1102.36
2020-1202.82
2021-0102.44
2021-0203.17
2021-0303
2021-0404.14
2021-0504.25
2021-0603.44
2021-0701.75
2021-0803.86
2021-0903.44
2021-1002.5
2021-1102.2
2021-1203.29
2022-0103.67
2022-0203.5
2022-0302.14
2022-0401
2022-0502.25
2022-0703
2022-0801
2022-1101
2022-1201
2023-0102.5
2023-0201
2023-0303
2023-0401.5
2023-0503
2023-0601
2023-0703.5
2023-0801.5
2023-0901
2023-1001.5
2023-1101
2024-0101.8
2024-0302
2024-0401
2024-0501
2024-0601.5
2024-0701.78
2024-0803
2024-0901
2024-1001
2024-1101.6
2024-1201.5
2025-0101.33
2025-0201
2025-0312
2025-0401.8
2025-0503.67
2025-0601.5
2025-0703
2025-0801
2025-0901.6
2025-1002
2025-1101.25
2025-1201.43
2026-0101.6
2026-0201.8
2026-0301
2026-0401.43
2026-0501.89
2026-0603.06
This device (reports/month)Average device in KGX (reports/device/month)
Failure-mode summaryAI-generated

1 linked report narrative available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-03-101038758-2024-00036InjuryAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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