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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.

9 linked reportsInjury 9
23562019-01: 0 reports for this device; peer average 2.5/device2019-07: 0 reports for this device; peer average 3/device2020-02: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 3/device2021-12: 3 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 1/device2023-08: 6 reports for this device; peer average 6/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 3/device2025-05: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 2/device010702091203041103080102040503
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.5
2019-0703
2020-0202
2021-0903
2021-1233
2022-0301
2022-0402
2022-1102
2023-0301
2023-0866
2025-0102
2025-0202
2025-0403
2025-0501
2026-0302
This device (reports/month)Average device in KNA (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2023-08-099610612-2023-00185InjuryAvailablecatalog number
2023-08-092916714-2023-00083InjuryAvailablecatalog number
2021-12-319610612-2021-00794InjuryAvailablecatalog number

Showing the most recent 3 of 9 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-07-11NAINo action indicatedAesculap Inc0
2025-07-11NAINo action indicatedAesculap Inc0
2022-07-21NAINo action indicatedAesculap AG0
2022-07-21NAINo action indicatedAesculap AG0
2021-08-11VAIVoluntary action indicatedAesculap Inc3
2021-08-11VAIVoluntary action indicatedAesculap Inc3
2018-06-13VAIVoluntary action indicatedAesculap Inc0
2018-06-13VAIVoluntary action indicatedAesculap Inc0
2016-09-22NAINo action indicatedAesculap AG0
2016-09-22NAINo action indicatedAesculap AG0
2016-09-14VAIVoluntary action indicatedAesculap Inc0
2016-09-14VAIVoluntary action indicatedAesculap Inc0
2016-07-13NAINo action indicatedAesculap Inc0
2016-07-13NAINo action indicatedAesculap Inc0
2015-07-16NAINo action indicatedAesculap AG1
2015-07-16NAINo action indicatedAesculap AG1
2015-05-05NAINo action indicatedAesculap Inc0
2015-05-05NAINo action indicatedAesculap Inc0
2014-10-23NAINo action indicatedAesculap Inc0
2014-10-23NAINo action indicatedAesculap Inc0
2011-09-26WLWarning LetterAesculap AG—
2011-09-26WLWarning LetterAesculap AG—
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