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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
InitiatedRecall #ClassStatusReasonQuantityLink basis
2022-10-06Z-0263-2023Class IIOpen, ClassifiedDuring a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.Distribution: Worldwide distribution.554,200 unitscode info di
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-06-24NAINo action indicated3m Company0
2026-06-24NAINo action indicated3m Company0
2019-04-17VAIVoluntary action indicated3M4
2017-11-27NAINo action indicated3M Company0
2016-12-08NAINo action indicated3M Company0
2016-12-08NAINo action indicated3M Company0
2016-12-06NAINo action indicated3M Company0
2016-09-14NAINo action indicated3M Company0
2015-11-06VAIVoluntary action indicated3M Company1
2015-03-19OAIOfficial action indicated3m Canada Company5
2014-07-09NAINo action indicated3M Co0
2014-07-09NAINo action indicated3M Co0
2014-06-26NAINo action indicated3M Company0
2014-06-26NAINo action indicated3M Company0
2014-04-25NAINo action indicated3M Company0
2013-12-13NAINo action indicated3M Company0
2013-08-16NAINo action indicated3m Company0
2013-08-16NAINo action indicated3m Company0
2013-03-28NAINo action indicated3M Company1
2012-12-05NAINo action indicated3M COMPANY0
2010-06-07WLWarning Letter3M Company—
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