ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE
|
Back to Search Results |
|
Catalog Number 94151EC |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Foreign Body Reaction (1868); Inflammation (1932); Skin Discoloration (2074)
|
Event Date 04/15/2019 |
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 events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.A review of the device history record has been initiated.If any deviations or non-conformance's are found, a supplemental medwatch will be submitted.This is a known potential adverse event addressed in the product labeling.
|
|
Event Description
|
Patient reports that injections with 1 ml juvederm® volbella¿ with lidocaine to the corner of mouth (both sides, upper left lip) and 1 ml juvéderm¿ voluma¿ with lidocaine to the nose wing ¿caused a super problem." 2 months post injection, deformation noted.Huge nodes appeared in the region injected with juvederm® volbella¿ with lidocaine."surgical removal" performed one month post symptom apparition.3 days later an anatomopathological was performed noting a "foreign body reaction" of the mucosa of the cheek/left side.12 days later a biopsy was completed confirming the diagnosis.Triancil was applied directly to the lesion 6 days later.Symptoms are ongoing.The nodules are smaller, but they exist.This is the same event and the same patient reported under mdr id# 3005113652-2019-00511 ((b)(4)).This mdr is being submitted for the first suspect product, juvederm® volbella¿ with lidocaine.
|
|
Search Alerts/Recalls
|
|
|