Catalog Number UNK VOLLURE |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Obstruction/Occlusion (2422)
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Event Date 01/24/2022 |
Event Type
Injury
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Event Description
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Healthcare professional reported that a patient was injected with juvéderm® voluma¿ xc in midface and chin with juvéderm® vollure¿ xc in perioral creases.Three days later, patient complained of swelling and blisters, which further noted as "artial occlusion." that same day, nurse practitioner administered 12 vials of hylenex and another 6 vials of hylenex under guided ultrasound the next day.This is the same event and the same patient reported under mdr id # 3005113652-2022-00081 (allergan complaint #(b)(4)).This mdr is being submitted for the suspect product, juvéderm® vollure¿ xc.
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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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Manufacturer Narrative
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Clarification to h6: the filler was injected into the patient and is not accessible for return.The syringe was discarded.
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Event Description
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Additional information reported 2 ml of juvéderm® voluma¿ xc was injected in the chin and 1-2 ml of juvéderm® vollure¿ xc was injected in the nasolabial folds.Diagnostic tests noted ¿hand held ultrasound¿ with results ¿vascular occlusion." event has resolved one day after date of when event first noticed.
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Search Alerts/Recalls
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