ALLERGAN (PRINGY) JUVEDERM ULTRA PLUS XC 0,8ML (1 ML COC); IMPLANT, DERMAL, FOR AESTHETIC USE
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Catalog Number 94155ED |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Obstruction/Occlusion (2422)
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Event Date 06/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The filler was injected into the patient and is not accessible for return.The syringe has been discarded.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.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.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.This is a known potential adverse event addressed in the product labeling.
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Event Description
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Healthcare professional (hcp) reported patient was infected in the chin with juvéderm® voluma® with lidocaine and juvéderm® ultra plus xc.Patient experienced an occlusion the next day, which patient reported to hcp two days later.Hcp then treated with red light, hirudoid® bruise cream, and hyaluronidase ¿full lower chin and surrounds flood.Cap refill was less 2 to whitened area on apex of chin, pain and reticulated rash noted on review.¿ there was no permanent damage.The event resolved 4 days later.This is the same event and the same patient reported under mdr id# 3005113652-2022-00428 (allergan complaint #pr (b)(4).This mdr is being submitted for the suspect product, juvéderm® ultra plus xc.
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