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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
Hypersensitivity/Allergic reaction (1907)
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Event Type
Injury
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Event Description
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Healthcare professional (hcp) reported a patient was injected in the lips with juvéderm volbella® xc.That same evening and into the next day, the patient experienced ¿severe swelling and trouble swallowing sips of water.¿ the patient reported they are sensitive to many medications and has many food allergies.The patient has been injected with other products previously but did not remember which ones and had reactions with those, but the swelling was worse this time.
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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.The filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.This is a known potential adverse event addressed in the product labeling.
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Search Alerts/Recalls
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