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.
|
Healthcare professional reported a patient was injected with juvéderm® voluma® with lidocaine and juvederm® volift¿ with lidocaine in the cheek and lips.Approximately 4-6 months later, patient developed "inflammatory reaction + hard nodules." treatment was noted as "prednisone, hyaluronidase & biaxin." it is unknown if events have resolved.This is the same event and the same patient reported under mdr id # 3005113652-2020-00751 (allergan complaint #(b)(4)).This mdr is being submitted for the suspect product, juvederm® volift¿ with lidocaine.
|