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Catalog Number UNK VOLBELLA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vascular System (Circulation), Impaired (2572)
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Event Type
Injury
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Manufacturer Narrative
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The filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.This is a known potential adverse event addressed in the product labeling.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.
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Event Description
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Healthcare professional (hcp) reported that a patient was injected in the lower tear trough with juvéderm volbella® xc.Hcp ¿suspected vascular occlusion approximately 12 hours after injection¿.Patient reported pain, discoloration, and numbness distal to the injection site, including tip of the nose and lip.Patient was treated with hyaluronidase and low dose aspirin.The condition is improving.
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Search Alerts/Recalls
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