MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLBELLA W/LIDO 2X1ML EAME SKU1; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 96658JR

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

Patient Problems Inflammation (1932); Skin Inflammation/ Irritation (4545)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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 reports patient injected with 1 ml of juvéderm® volbella¿ with lidocaine in the dark circles.Injection site confirmed to be "asepsis" prior to injection.During injection, tyndall effect and granulomas formed that did not improve with manual massage.No report of biopsy of granulomas to confirm.The next morning, patient presented with edema at the injection site with granulomas and tyndall effect persists.The surrounding area was swollen and bluish.Event ongoing.

Event Description

Additionally, healthcare professional reported they treated the patient with hyaluronidase and event has resolved completely as there was no "granuloma, it was product superficially placed.".

• Brand Name: JUVEDERM VOLBELLA W/LIDO 2X1ML EAME SKU1
• 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: 11078107
• MDR Text Key: 223800117
• Report Number: 3005113652-2020-00815
• 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,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 96658JR
• Device Lot Number: V15LB00070
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR