Catalog Number 94640 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Obstruction/Occlusion (2422)
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Event Date 09/14/2022 |
Event Type
Injury
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Manufacturer Narrative
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The filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.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.This is a known potential adverse event addressed in the product labeling.
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Event Description
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Healthcare professional reported patient was injected in the v4 region with juvéderm® voluma¿ xc and patient experienced "blanced." they were treated with nitropaste and hyaluronidase.
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Event Description
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Additional details received noting that 0.1mls of juvéderm® voluma¿ xc were injected.Patient was treated with 3 vials of hyaluronidase.Event resolved same day.
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Manufacturer Narrative
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Clarification to h.6.Type of investigation code: the syringe has been discarded.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.
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Event Description
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Healthcare professional reported patient was injected in the v4 region with juvéderm® voluma¿ xc and patient experienced "balanced." they were treated with nitropaste and hyaluronidase.
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Manufacturer Narrative
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Corrected data.
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Search Alerts/Recalls
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