MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94728JR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body Reaction (1868)

Event Date 09/16/2021

Event Type  Injury  

Event Description

Healthcare professional reported injecting a patient with 0.8 ml of juvéderm® volbella¿ with lidocaine in the tear trough and eye bag area.A year and a half later, the patient developed a lump in the cheek, cellulitis on the right side of the face with "malar formation to be studied" and had inflammation in the eye bag area.A biopsy was performed of the lump and confirmed a granulomatoses reaction.The patient was treated with doflazocoir.The event is ongoing.

Manufacturer Narrative

(b)(4).The filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event of "granuloma" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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.

• Brand Name: VOLBELLA WITH LIDOCAINE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• MDR Report Key: 12611729
• MDR Text Key: 281922800
• Report Number: 3005113652-2021-03309
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 94728JR
• Device Lot Number: V15LA90333
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR