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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.

4 linked reportsInjury 4
11222019-11: 0 reports for this device; peer average 2/device2021-01: 0 reports for this device; peer average 2/device2021-03: 2 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 2/device2025-06: 2 reports for this device; peer average 2/device110103121006
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-1102
2021-0102
2021-0322
2022-1201
2023-1002
2025-0622
This device (reports/month)Average device in GYB (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-06-163001236514-2025-00002InjuryAvailableexact di
2021-03-183001236514-2021-00002InjuryAvailableexact di

Showing the most recent 2 of 4 linked reports.

Regulatory clearances

    Predicate lineage

    K022006

    Cited as predicate by: K200402, K232001

    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
    2017-03-09NAINo action indicatedNSE Products, Inc.0
    2017-03-09NAINo action indicatedNSE Products, Inc.0
    2012-12-17NAINo action indicatedNSE Products, Inc.1
    2012-12-17NAINo action indicatedNSE Products, Inc.1
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