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Catalog Number 94155 |
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 Date 08/27/2020 |
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 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.
This is a known potential adverse event addressed in the product labeling.
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Event Description
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Healthcare professional reports patient injection with one syringe of juvéderm® ultra plus xc in the lips.
Patient experienced ¿a vascular occlusion on the right side of the lips, immediately.
¿ the patient was treated with 5 vials of hylenex, nitro paste, and steroids.
The symptoms are ¿ongoing, but is crusting up.
¿.
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Search Alerts/Recalls
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