Catalog Number 94154 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Vascular System (Circulation), Impaired (2572)
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Event Type
Injury
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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.Clarification: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.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.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 to company representative that a patient experienced an "occlusion" on the bottom lip shortly after they were injected in the lips with 1 syringe of juvéderm® ultra xc.Treatment is noted as hyaluronidase and warm compress.Event has resolved.
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Event Description
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Healthcare professional reported to company representative that a patient experienced an "occlusion" on the bottom lip shortly after they were injected in the lips with 1 syringe of juvéderm® ultra xc.Treatment is noted as hyaluronidase and warm compress.Event has resolved.
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Manufacturer Narrative
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Additional, changed, and/or corrected data: h.6.
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Search Alerts/Recalls
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