Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.The filler was injected into the patient and is not accessible for return.The syringe was discarded.This is a known potential adverse event addressed in the product labeling.
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Healthcare professional reported injecting a patient in the tear trough with 1 ml of juvéderm® voluma¿ xc.A year later, the patient received their first covid-19 vaccines and the second one a month later.A month after the 2nd vaccine, the patient was injected in the lips with 1 syringe of juvéderm® volbella¿ xc and in the cheeks with 2 syringes of juvéderm® voluma¿ xc.Approximately two months later, the patient experienced ¿swelling, induration and nodules," "latent hypersensitivity reaction," "red, swollen nodules noted under in right tear trough" and "hard to the touch and swollen" lips.The patient self-treated with benadryl.Two months later, the patient visited the office and was given a tapered steroid dose, 3 (20 mg) tabs for 2 days, 2 (20 mg) tabs for 2 days, and 1 (20 mg) tab for 3 days.When treatment ended, the event resumed.The event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2022-00182 (allergan complaint # (b)(4)) and mdr id# 3005113652-2022-00183 (allergan complaint # (b)(4)).This mdr is being submitted for the first injection of suspect product, juvéderm® voluma¿ xc.
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