Catalog Number UNK JUVEDERM ULTRA XC/LIDO |
Device Problem
Improper or Incorrect Procedure or Method (2017)
|
Patient Problem
Vascular System (Circulation), Impaired (2572)
|
Event Date 07/29/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
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.This is a known potential adverse event addressed in the product labeling.
|
|
Event Description
|
Health professional reported "development of dusky appearance to r upper lip suggesting vascular occlusion", "hylased immediately & resolved" after a patient was injected in the lips with.8 ml of juvéderm® ultra.Treatment is noted as ¿hyalase 1500 units x 2 (1 hr apart)." event has resolved.
|
|
Event Description
|
Health professional reported "development of dusky appearance to r upper lip suggesting vascular occlusion", "hylased immediately & resolved" after a patient was injected in the lips with.8 ml of juvéderm® ultra.Treatment is noted as ¿hyalase (b)(4)units x 2 (1 hr apart)." event has resolved.
|
|
Manufacturer Narrative
|
Additional, changed, and/or corrected data: d.4.
|
|
Search Alerts/Recalls
|