MAUDE Adverse Event Report: 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	Inflammation (1932)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported injecting a patient with two syringes of juvéderm volbella® xc in the tear trough and midface.Approximately 11 months post injections, the patient started experiencing ¿irritation.¿ four months post symptom onset, the patient saw their injector for the irritation.The following month the patient was seen again ¿for ongoing irritation and swelling.¿ the patient was treated with medrol pack.Three days later, the patient visited another hcp (dermatologist) for swelling with no diagnosis.Six days later, the patient saw the same hcp (dermatologist) for swelling again and treated the patient with a stronger dose of prednisone.About two and a half months later, the hcp ordered a facial x-ray and two days later, the hcp recommended an ¿mri ocular or ent¿, that same day the patient had a full blood panel including autoimmune.The following day the hcp suggested seeing an ocular surgeon immediately.The next day, an mri with contrast was performed which ¿stated it might be infectious or neoplastic.Four days later, the patient saw an oculoplastic and orbital surgeon who stated that it could be the filler.The following day the patient saw a plastic surgeon and told them their condition might possibly have been caused by filler and referred patient to an ocular surgeon due to location of filler.¿ six days later, the patient saw again the oculoplastic and orbital surgeon and they stated the patient¿s condition was most likely caused by filler and they injected vitrase and the filler started to migrate and worsen.The hcp was ¿100% certain this is filler that had to be dissolved.¿ the patent was treated with hylenex® in both malar bags.About two weeks later, the patent was treated again with hylenex® in both malar bags.Two weeks later, the patent was treated again with heavier shots of lidocaine and they used cannula to flood both sides with hylenex®.About one month later, the patent was treated again with hylenex® in both malar bags.Three weeks later, the patent was treated again with hylenex® in both malar bags.Twenty-one days later, the patient visited the hcp to discuss ongoing eye irritation which could be due to filler attempting to get out.Five days later, the patent was treated again with hylenex® in the right malar bag only and advised that the filler may be gone and the patient should continue to monitor the situation.The hcp anticipates the patient will need 3-4 laser treatments to address the hyperpigmentation caused by reaction.Symptoms are ongoing.
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.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: JUVEDERM VOLBELLA XC 2 X 1ML 32G
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): 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: 22889124
• Report Number: 3005113652-2025-00768
• Device Sequence Number: 20068537
• Product Code: LMH
• UDI-Device Identifier: 10888628043541
• UDI-Public: (01)10888628043541(10)1000512653(11)220504(17)240404
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 08/25/2025

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: 04/04/2024
• Device Catalogue Number: 96181
• Device Lot Number: 1000512653
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female