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	Cancer (3262)
Date of Event	06/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Via clinical study, a healthcare professional reported injecting a patient in the midface, temples, and chin with 5.1 ml of juvéderm® voluma¿ xc, in the lips and perioral with 1.15 ml of juvéderm® volbella¿ xc, and in the cheek with 3 ml of skinvive¿ by juvéderm®.A month later, the patient was injected in the midface, chin, and temples with 5.1 ml of juvéderm® voluma¿ xc, in the lips with 0.2 ml of juvéderm® volbella¿ xc, in the jawline with 0.7 ml of juvéderm® volux¿ xc, in the nasolabial folds with 1 ml of juvéderm® vollure¿ xc, and in the cheek with 1 ml of skinvive¿ by juvéderm®.A month later, the patient was injected in the nasolabial folds with 0.6 ml of juvéderm® vollure¿ xc and in the jawline with 0.3 ml of juvéderm® volux¿ xc.Two months later, the patient experienced non-device related ¿left sided squamous cell carcinoma of the tongue.¿ two days later, the patient experienced non-device related ¿urinary tract infection¿ and ¿dehydration.¿ the ¿dehydration¿ resolved that day, and the ¿urinary tract infection¿ resolved a week later.The ¿left sided squamous cell carcinoma of the tongue¿ was 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.Abbvie is unable to confirm with the healthcare professional; therefore, additional event, product, or patient details are not attainable.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.The event of "left sided squamous cell carcinoma of the tongue", deemed not device related, is considered an unexpected adverse drug experience.

• 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 ; +1(847)936-6324
• MDR Report Key: 50060755
• Report Number: 3005113652-2026-00838
• Device Sequence Number: 10693971
• Product Code: LMH
• UDI-Device Identifier: 10888628043541
• UDI-Public: (01)10888628043541(17)260915(10)1002840353
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2026

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: 09/15/2026
• Device Catalogue Number: 96181
• Device Lot Number: 1002840353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Supplement Date Received by Manufacturer: 07/29/2026; 09/18/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 07/31/2026; 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 120 LB
• Patient Race: White