|
Catalog Number 94154ED |
Device Problem
Improper or Incorrect Procedure or Method (2017)
|
Patient Problem
Obstruction/Occlusion (2422)
|
Event Date 05/12/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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.
|
|
Event Description
|
Healthcare professional (hcp) reported that patient was injected with juvéderm ultra® xc.Pre-treatment was numbing.That day, hcp "noted color change to bottom lip, sluggish cap refill." patient was treated by massaging the area and applying heat.Then, patient was treated with hyalase® "to pinpoint." after treatment, color returned to normal.Symptoms resolved same day.
|
|
Search Alerts/Recalls
|
|
|