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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
  • 510(k)K102785Substantially equivalent (SESE) · 2011-08-19clearance family

Predicate lineage

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
2024-06-03VAIVoluntary action indicatedTriMed Inc.2
2024-06-03VAIVoluntary action indicatedTriMed Inc.2
2019-08-14NAINo action indicatedTriMed Inc.0
2019-08-14NAINo action indicatedTriMed Inc.0
2017-11-17VAIVoluntary action indicatedTriMed Inc.6
2017-11-17VAIVoluntary action indicatedTriMed Inc.6
2017-01-12VAIVoluntary action indicatedTriMed Inc.11
2017-01-12VAIVoluntary action indicatedTriMed Inc.11
2016-06-30WLWarning LetterTriMed Inc.—
2016-06-30WLWarning LetterTriMed Inc.—
2016-03-18OAIOfficial action indicatedTriMed Inc.13
2016-03-18OAIOfficial action indicatedTriMed Inc.13
2012-01-25VAIVoluntary action indicatedTriMed Inc.5
2012-01-25VAIVoluntary action indicatedTriMed Inc.5
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