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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.

1 linked reportMalfunction 1
23562019-08: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 6/device2025-10: 1 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)
2019-0802
2023-0802
2024-0206
2025-1011
This device (reports/month)Average device in FNP (reports/device/month)
Failure-mode summaryAI-generated

1 linked report narrative available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-10-178043817-2025-00009MalfunctionAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-04-22NAINo action indicatedMICROTEK MEDICAL LLC0
2018-06-15NAINo action indicatedMICROTEK MEDICAL LLC0
2016-08-03VAIVoluntary action indicatedMicrotek Medical Inc4
2011-06-22NAINo action indicatedMicrotek Medical Inc0
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