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	Off-Label Use (1494)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional (hcp) reported that patient was injected with one syringe of an expired juvéderm volbella® xc in the lips.Approximately three weeks after, the patient was seen for follow up with no complaints.About two months post injections, the patient called the office stating they were experiencing ¿balls on my upper and lower lip possible granulomas and persistent swelling.¿ the following day the patient said their lips are ¿now felt hard.¿ the patient was instructed to take ¿benadryl or zyrtek and suggested them come into the office for a consult which patient declined.¿ five days later the patient reported ¿i drank alcohol last night and woke up this morning with more swelling and went to urgent care and was administered a steroid injection.¿ the following day, the patient went to ¿the office with swelling to upper and lower lip and was prescribed prednisone.Hylenex® was administered (2cc's on top and 2 cc's on bottom) as well as a decadron injection and a iv drip of myers cocktail for immunity.Two days later, the patient stated "swelling is worse".Seven days later, the patient went back to the office and was administered hylenex® (1cc on top lip and 1cc on bottom lip).The hcp stated "the swelling would go down and lips would soften while taking steroid but once the steroid was gone the swelling would come back." the syringe has been discarded.The 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.This is a known potential adverse event addressed in the product labeling.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.

• 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): ALLERGAN (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: 22370556
• Report Number: 3005113652-2025-00590
• Device Sequence Number: 17240604
• Product Code: LMH
• UDI-Device Identifier: 10888628043541
• UDI-Public: (01)10888628043541(10)1000603160(11)230421(17)250321
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2025
• Device Catalogue Number: 96181
• Device Lot Number: 1000603160
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2023
• 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 Sex: Female