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	Nodule (4551)
Date of Event	05/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The healthcare professional reported that the patient was injected with 0.5 ml of juvéderm® volbella¿ xc in the vermilion lips.Two months later, patient was injected with 0.3 ml of juvéderm® volbella¿ xc in the lips.Two months later, patient was injected with 1 ml of juvéderm® voluma¿ xc in the cheeks.Two weeks later, patient developed 3 lumps inside bottom lip and 1 top right upper lip at cupid's bow with burning sensation and swellings.Patient felt run down without fever.The patient was treated with steroids and valtrex.Two months later, patient was treated with 3 rounds po steroids, valtrex, antihistamine, 0.2 ml of hylenex, and r/u lisinopril reaction as culprit of oral swelling.Symptoms resolved approximately 3 months after onset.This record is for the 1st injection of juvéderm® volbella¿ xc.
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.The event is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.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: 23733377
• Report Number: 3005113652-2025-01111
• Device Sequence Number: 13402547
• Product Code: LMH
• UDI-Device Identifier: 10888628043541
• UDI-Public: (01)10888628043541(10)1001411043(11)240228(17)260128
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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: 01/28/2026
• Device Catalogue Number: 96181
• Device Lot Number: 1001411043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2024
• 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: 46 YR
• Patient Sex: Female