Healthcare professional reported that a patient experienced ¿a vascular occlusion in the nasal labial folds, 30 minutes later¿ after they were injected in the nasolabial folds with one syringe of juvéderm® ultra plus xc.Treatment is noted as hylenex, aspirin, warm compress, massage, and two (b)(6).It was noted that it ¿has resolved, but there is some bruising and soreness.¿.
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(b)(4).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.The filler was injected into the patient and is not accessible for return.The syringe was discarded.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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