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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.

26 linked reportsInjury 18Malfunction 8
12342020-08: 0 reports for this device; peer average 3/device2021-09: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 2/device2022-01: 2 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1/device2022-11: 2 reports for this device; peer average 2/device2022-12: 2 reports for this device; peer average 2/device2023-01: 2 reports for this device; peer average 2/device2023-04: 2 reports for this device; peer average 2/device2023-05: 2 reports for this device; peer average 2/device2023-07: 2 reports for this device; peer average 2/device2023-08: 4 reports for this device; peer average 4/device2023-09: 2 reports for this device; peer average 2/device2023-10: 2 reports for this device; peer average 1.5/device2023-12: 4 reports for this device; peer average 4/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1/device0809120107081112010405070809101201020403080903
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0803
2021-0901
2021-1202
2022-0122
2022-0701
2022-0801
2022-1122
2022-1222
2023-0122
2023-0422
2023-0522
2023-0722
2023-0844
2023-0922
2023-1021.5
2023-1244
2024-0101
2024-0201
2024-0401
2025-0301
2025-0802
2025-0901
2026-0301
This device (reports/month)Average device in SBF (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2023-12-243016571711-2023-00018MalfunctionAvailableexact di
2023-12-243016571711-2023-00017MalfunctionAvailableexact di
2023-12-173016571711-2023-00015MalfunctionAvailableexact di
2023-12-173016571711-2023-00016MalfunctionAvailableexact di
2023-10-243016571711-2023-00013MalfunctionAvailableexact di
2023-10-243016571711-2023-00014MalfunctionAvailableexact di
2023-09-213016571711-2023-00011InjuryAvailableexact di
2023-09-213016571711-2023-00012InjuryAvailableexact di
2023-08-103016571711-2023-00009InjuryAvailableexact di
2023-08-103016571711-2023-00010InjuryAvailableexact di
2023-08-023016571711-2023-00007InjuryAvailableexact di
2023-08-023016571711-2023-00008InjuryAvailableexact di
2023-07-243016571711-2023-00006MalfunctionAvailableexact di
2023-07-243016571711-2023-00005MalfunctionAvailableexact di
2023-05-163016571711-2023-00003InjuryAvailableexact di
Showing 1–15 of 26
Regulatory clearances

    Predicate lineage

    Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

    Manufacturer compliance record

    None in the loaded window.

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