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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.

8 linked reportsMalfunction 8
23562019-08: 2 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 2/device2024-02: 6 reports for this device; peer average 6/device2025-10: 0 reports for this device; peer average 1/device08080210
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0822
2023-0802
2024-0266
2025-1001
This device (reports/month)Average device in FNP (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2024-02-2818796294MalfunctionAvailablecatalog number
2024-02-2818796325MalfunctionAvailablecatalog number
2019-08-278935515MalfunctionAvailablecatalog number

Showing the most recent 3 of 8 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2023-05-19VAIVoluntary action indicatedMedegen Medical Products, LLC5
2023-05-19VAIVoluntary action indicatedMedegen Medical Products, LLC5
2019-10-10VAIVoluntary action indicatedMedegen Medical Products, LLC6
2019-10-10VAIVoluntary action indicatedMedegen Medical Products, LLC6
2018-01-31VAIVoluntary action indicatedMedegen Medical Products, LLC13
2018-01-31VAIVoluntary action indicatedMedegen Medical Products, LLC13
2017-09-22NAINo action indicatedMedegen Medical Products0
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