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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)K100103Substantially equivalent (SESE) · 2010-12-15clearance family
Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2018-12-14VAIVoluntary action indicatedHelena Laboratories, Corp.4
2018-12-14VAIVoluntary action indicatedHelena Laboratories, Corp.4
2017-07-21OAIOfficial action indicatedHelena Laboratories, Corp.8
2017-07-21OAIOfficial action indicatedHelena Laboratories, Corp.8
2017-07-14NAINo action indicatedHelena Laboratories, Inc0
2017-07-14NAINo action indicatedHelena Laboratories, Inc0
2013-03-01VAIVoluntary action indicatedHelena Laboratories, Inc1
2013-03-01VAIVoluntary action indicatedHelena Laboratories, Corp.9
2013-03-01VAIVoluntary action indicatedHelena Laboratories, Inc1
2013-03-01VAIVoluntary action indicatedHelena Laboratories, Corp.9
2010-10-29VAIVoluntary action indicatedHelena Laboratories, Corp.0
2010-10-29VAIVoluntary action indicatedHelena Laboratories, Corp.0
2010-10-28NAINo action indicatedHelena Laboratories, Inc0
2010-10-28NAINo action indicatedHelena Laboratories, Inc0
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