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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.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2021-09-02NAINo action indicatedApplied Medical Resources Corp0
2021-09-02NAINo action indicatedApplied Medical Resources Corp0
2018-11-20NAINo action indicatedApplied Medical Resources Corp0
2018-11-20NAINo action indicatedApplied Medical Resources Corp0
2017-03-31VAIVoluntary action indicatedApplied Medical Resources Corp0
2017-03-31VAIVoluntary action indicatedApplied Medical Resources Corp0
2015-12-03NAINo action indicatedApplied Medical Resources Corporation0
2015-10-14OAIOfficial action indicatedApplied Medical Resources Corp8
2015-10-14OAIOfficial action indicatedApplied Medical Resources Corp8
2015-04-10WLWarning LetterApplied Medical Resources Corp—
2015-04-10WLWarning LetterApplied Medical Resources Corp—
2014-12-16OAIOfficial action indicatedApplied Medical Resources Corp8
2014-12-16NAINo action indicatedApplied Medical Distribution Center0
2014-12-16OAIOfficial action indicatedApplied Medical Resources Corp8
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