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 Codes	Skin Inflammation/ Irritation (4545); Nodule (4551)
Date of Event	03/01/2025
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.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 or Problem Description
Healthcare professional reported injecting a patient in the cheek/midface, oral commissures, and nasolabial folds with 1 ml of juvéderm voluma® xc and 0.6 ml of juvéderm volbella® xc.The patient noticed a ¿pimple¿ in each oral commissure of the mouth that had ¿off-white colored drainage.¿ two months later, the patient was injected with botox® and complained of ¿two small bumps (about 2mm diameter bilaterally in the oral commissures, cheeks, and nasolabial folds.The patient was treated that day with 3 u of hylenex.A weeks later, the patient that their face looked ¿weird and droopy.Twenty-two days later, the patient experienced ¿swelling and nodules¿ in the cheeks and marionette lines around the mouth.The healthcare professional noted that the patient ¿lost a significant amount of weight,¿ and when asked, the patient reported actively losing weight for 7 months but did report ¿stomach pain, cold sweats, weight loss, daily fever and resting hr high¿ the month after injection.The patient also reported having non-device related ¿shingles¿ five months later.Two days after check-up, the patient was treated with a medrol dosepak for 6 days.Six days later, the patient was also given augmentin 875/125 1 tab bid for 7 days.The event returned after initial improvement at 70%.Event is ongoing.This file captured the juvéderm volbella® xc.

• 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: 23649210
• Report Number: 3005113652-2025-01075
• Device Sequence Number: 4823337
• Product Code: LMH
• UDI-Device Identifier: 10888628043541
• UDI-Public: (01)10888628043541(10)1000971363(11)230911(17)250811
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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: 08/11/2025
• Device Catalogue Number: 96181
• Device Lot Number: 1000971363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2023
• 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 Age: 47 YR
• Patient Sex: Female
• Patient Race: White