MAUDE Adverse Event Report: Pringy SKINVIVE by JUVEDERM XC 2x1 mL; implant, dermal, for aesthetic use

Catalog Number	98307
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.
Event or Problem Description
Healthcare professional additionally reported that about a month after diagnosis, patient had surgery for "excision of squamous cell carcinoma on tongue.¿.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: b2,b5, b6, b7, h6, h10.

• Brand Name: SKINVIVE by JUVEDERM XC 2x1 mL
• 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: 50060720
• Report Number: 3005113652-2026-00836
• Device Sequence Number: 10745885
• Product Code: LMH
• UDI-Device Identifier: 10840228300066
• UDI-Public: (01)10840228300066(17)270114(10)1003543586
• 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: 01/14/2025
• Device Catalogue Number: 98307
• Device Lot Number: 1003543586
• 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: 02/14/2025
• 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