|
Catalog Number 94154ED |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Vascular System (Circulation), Impaired (2572)
|
Event Date 06/02/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The event of "occlusion" 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 completed.No deviations or non-conformances noted.This is a known potential adverse event addressed in the product labeling.
|
|
Event Description
|
Health professional reported injecting a patient in the lip with juvéderm ultra® xc.The patient experienced ¿corner of the mouth left side upper and lower occlusion.¿ patient was treated with arnica cream after injection.The lip was massaged.The next day, patient received hyalase, and again the day after."the color of the lips returned".Physician planned to "apply the clinic led light every 24 hours".Symptoms resolved 4 days after onset.
|
|
Search Alerts/Recalls
|
|
|