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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
2021-08-19VAIVoluntary action indicatedDenterprise International, Inc.9
2021-08-19VAIVoluntary action indicatedDenterprise International, Inc.9
2019-10-09WLWarning LetterDenterprise International, Inc.—
2019-10-09WLWarning LetterDenterprise International, Inc.—
2019-05-06OAIOfficial action indicatedDenterprise International, Inc.10
2019-05-06OAIOfficial action indicatedDenterprise International, Inc.10
2018-03-12OAIOfficial action indicatedDenterprise International, Inc.0
2018-03-12OAIOfficial action indicatedDenterprise International, Inc.0
2016-07-29VAIVoluntary action indicatedDenterprise International, Inc.16
2016-07-29VAIVoluntary action indicatedDenterprise International, Inc.16
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