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Catalog Number 94155 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vascular System (Circulation), Impaired (2572)
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Event Date 12/31/2019 |
Event Type
Injury
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Manufacturer Narrative
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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.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.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 have had injected the patient in the right nasolabial fold with a juvederm ultra plus xc.On the same day, the patient presented vascular occlusion in the right nasolabial fold, nose, and forehead.10 days later, the patient¿s right nasolabial fold was treated with hylenex, the affected sites were treated with warm compress with massage; nitobid paste was also applied to all the affected sites and 325 mg asa was provided.The symptoms have not resolved.
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Search Alerts/Recalls
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