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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
2023-07-12NAINo action indicatedStandard Textile Co Inc0
2023-07-12NAINo action indicatedStandard Textile Co Inc0
2020-02-28VAIVoluntary action indicatedStandard Textile Co Inc3
2020-02-28VAIVoluntary action indicatedStandard Textile Co Inc3
2016-10-14VAIVoluntary action indicatedStandard Textile Co Inc3
2016-10-14VAIVoluntary action indicatedStandard Textile Co Inc3
2014-05-13NAINo action indicatedStandard Textile Co Inc0
2014-05-13NAINo action indicatedStandard Textile Co Inc0
2013-05-07WLWarning LetterStandard Textile Co Inc—
2013-05-07WLWarning LetterStandard Textile Co Inc—
2013-02-08OAIOfficial action indicatedStandard Textile Co Inc1
2013-02-08OAIOfficial action indicatedStandard Textile Co Inc1
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