|
Model Number 95834 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Angioedema (4536)
|
Event Date 02/03/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
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.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.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was discarded.Angioedema is a known potential adverse event addressed in the product labeling.
|
|
Event Description
|
Healthcare professional reports lip angioedema 4 year post treatment with juvéderm volbella® xc.Non-sedation antihistamine provided the day symptom appeared.The following day, symptoms resolved.
|
|
Event Description
|
Healthcare professional reports lip angioedema 4 year post treatment with juvéderm volbella® xc.Non-sedation antihistamine provided the day symptom appeared.The following day, symptoms resolved.
|
|
Manufacturer Narrative
|
Corrected data: a.4., h.6.
|
|
Search Alerts/Recalls
|
|
|