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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
2018-08-30NAINo action indicatedREMINGTON MEDICAL, S.A.0
2018-01-11NAINo action indicatedRemington Medical, Inc.0
2018-01-11NAINo action indicatedRemington Medical, Inc.0
2018-01-11NAINo action indicatedRemington Medical, Inc.0
2018-01-11NAINo action indicatedRemington Medical, Inc.0
2015-09-14WLWarning LetterREMINGTON MEDICAL, S.A.—
2015-06-25NAINo action indicatedREMINGTON MEDICAL, S.A.0
2014-11-24NAINo action indicatedRemington Medical, Inc.0
2014-11-24VAIVoluntary action indicatedRemington Medical, Inc.3
2014-11-24NAINo action indicatedRemington Medical, Inc.0
2014-11-24VAIVoluntary action indicatedRemington Medical, Inc.3
2014-08-14OAIOfficial action indicatedREMINGTON MEDICAL, S.A.9
2012-06-06VAIVoluntary action indicatedRemington Medical, Inc.1
2012-06-06VAIVoluntary action indicatedRemington Medical, Inc.2
2012-06-06VAIVoluntary action indicatedRemington Medical, Inc.2
2012-06-06VAIVoluntary action indicatedRemington Medical, Inc.1
2010-12-17VAIVoluntary action indicatedRemington Medical, Inc.5
2010-12-17VAIVoluntary action indicatedRemington Medical, Inc.1
2010-12-17VAIVoluntary action indicatedRemington Medical, Inc.5
2010-12-17VAIVoluntary action indicatedRemington Medical, Inc.1
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