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Catalog Number 95661 |
Device Problem
Off-Label Use (1494)
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Patient Problem
Skin Irritation (2076)
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Event Date 11/04/2020 |
Event Type
Injury
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Manufacturer Narrative
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Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.This is a known potential adverse event addressed in the product labeling.
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Event Description
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Healthcare professional reports patient injection with 1 syringe of juvéderm vollure¿ xc in the lips.Patient was "ok" 2, 4 and 5 weeks after injection.7 weeks after injection, patient's lips were ¿hard as a rock.¿ the injector treated patient with hylenex on day of symptom onset.Symptoms are ongoing.
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Event Description
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Approximately three and a half months post symptom onset, symptom resolved.
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Manufacturer Narrative
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A review of the device history record has been completed.No deviations or non-conformances noted.
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Search Alerts/Recalls
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