Patient reported being injected in the cheeks with one syringe of juvéderm® ultra plus xc and in the ¿smile lines¿ with one syringe of juvéderm vollure¿ xc.Seven months later, the patient was injected in the cheeks with one syringe of juvéderm voluma® xc and in the ¿smile lines¿ with one syringe of juvéderm vollure¿ xc.Thirteen months later, the patient was injected in the cheeks with one syringe of juvéderm voluma® xc and in the ¿smile lines¿ with one syringe of juvéderm vollure¿ xc.Two months later, the patient received their first pizer covid-19 vaccine and the second one 3 weeks later.Immediately, the patient was noted that they ¿looked tired¿ and ¿under the eyes had puffed up and it looked like bags under the eyes, and progressively got worse.¿ three months later, the patient was injected in the lips with half a syringe of juvéderm volbella® xc.A biopsy was performed 4 months later at another facility that confirmed the event was due to the filler, and it was dissolved.The patient will return to have more filler dissolved.The patient reported ¿lumps¿ under the eyes and that their face ¿sweats profusely¿ (unrelated to the device), as well as ¿cold sores¿ around the lips.The patient was treated with prednisone and augmentin.The event is ongoing.This is the same event and the same patient reported under mdr id # 3005113652-2021-03395 (allergan complaint # (b)(4)), mdr id # 3005113652-2021-03396 (allergan complaint # (b)(4)), mdr id # 3005113652-2021-03397 (allergan complaint # (b)(4)), mdr id # 3005113652-2021-03398 (allergan complaint # (b)(4)), mdr id # 3005113652-2021-03399 (allergan complaint # (b)(4)), and mdr id # 3005113652-2021-03400 (allergan complaint # (b)(4)).This mdr is being submitted for the first suspect product, juvéderm® ultra plus xc.
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Concomitant therapies: juvéderm vollure¿ xc.(b)(4).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 not returned for evaluation.This is a known potential adverse event addressed in the product labeling.
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