MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLBELLA XC 2 X 1ML 32G; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	96181
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clarification to h.6.Type of investigation code: 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 is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
A healthcare professional reported that patient was injected with juvéderm® volux¿ xc.Patient was previously injected with unk dermal filler.After the injection, patient started to have intermittent swelling in the area of filler.Patient was treated with hyaluronidase and steroids (injected and oral) to resolve.Patient continue to have recurrent episodes of swelling.Symptoms are ongoing.This is the same event and the same patient reported under abbvie complaint (b)(4).This mdr is being submitted for the suspect product, unk dermal filler.
Additional Manufacturer Narrative
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.
Event or Problem Description
A healthcare professional reported that patient was injected with juvéderm voluma® xc into the hands.Two and half months later, patient was injected with 2 ml of juvéderm® volux¿ xc in the jawline and 1 ml of juvéderm volbella® xc in the tear trough.Three months later, patient was injected with juvéderm® volux¿ xc in the jawline.The patient developed an inflammatory response at the site of previous juvéderm voluma® xc injection in the hands along with swelling in the areas where juvéderm® volux¿ xc has been injected.The patient was initially treated with oral antibiotics and steroids.About two months later, patient was administered a course of oral prednisone.About two months later, another round of prednisone and injections of hylenex into the affected areas on two occasions.A month later, another hylenex injections were administered.Patient continue to have recurrent episodes of swelling.Symptoms are ongoing.This is the same event and the same patient reported under abbvie complaint (b)(4).This mdr is being submitted for the third suspect product, juvéderm volbella® xc.

• Brand Name: JUVEDERM VOLBELLA XC 2 X 1ML 32G
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer (Section G): PRINGY; route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 22014435
• Report Number: 3005113652-2025-00461
• Device Sequence Number: 7985015
• Product Code: LMH
• UDI-Device Identifier: 10888628043541
• UDI-Public: (01)10888628043541(10)1000537856(11)220902(17)240802
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2024
• Device Catalogue Number: 96181
• Device Lot Number: 1000537856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 05/28/2025
• Date Device Manufactured: 09/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White