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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.

2 linked reportsInjury 2
12232019-01: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1.5/device2020-01: 0 reports for this device; peer average 1.33/device2020-07: 2 reports for this device; peer average 2/device2020-08: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1.5/device2022-06: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 1.5/device2022-10: 0 reports for this device; peer average 3/device2023-01: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1.5/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 2.25/device2024-09: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 2.5/device2025-06: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1.5/device0103040509100107080802030607100103040508060709030608
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0301
2019-0401
2019-0501
2019-0902
2019-1001.5
2020-0101.33
2020-0722
2020-0801
2021-0802
2022-0201
2022-0301.5
2022-0602
2022-0701.5
2022-1003
2023-0102
2023-0301
2023-0401
2023-0501
2023-0801.5
2024-0601
2024-0702.25
2024-0901
2025-0302.5
2025-0601
2025-0801.5
This device (reports/month)Average device in ETB (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2020-07-021000022662-2020-00001InjuryAvailableexact di

Showing the most recent 1 of 2 linked reports.

Regulatory clearances

    Predicate lineage

    K063374

    Cited as predicate by: K112616

    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
    DateTypeOutcomeFacilityCitations
    2016-05-27VAIVoluntary action indicatedGrace Medical, Inc.3
    2012-11-29NAINo action indicatedGrace Medical, Inc.0
    2010-01-08NAINo action indicatedGrace Medical, Inc.0
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