MAUDE Adverse Event Report: PRINGY JUVEDERM ULTRA PLUS XC TSK US; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	94155
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	02/12/2026
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.The event of "incontinence due to l4-l5 disc herniation", deemed not device related, is considered an unexpected adverse drug experience.
Event or Problem Description
Healthcare professional reported via clinical study injecting a patient with 0.7ml right temple, 0.7ml left temple, 1.3ml right cheek, 1.3ml left cheek, 2.0ml chin using juvéderm® voluma® xc, 1ml right jawline, 2ml left jawline using juvéderm® volux¿ xc, 0.7ml right nasolabial fold, 0.7ml left nasolabial fold using juvéderm® ultra plus xc, and 1ml right cheek, 1ml left cheek using skinvive¿ by juvéderm®.One month later, patient was injected with 1ml right temple, 1ml left temple, 1.4ml right mid-face, 2ml left mid-face using juvéderm® voluma® xc and 1.2ml left nasolabial fold using juvéderm® ultra plus xc.Three weeks later, patient developed non device related urticaria and eczema in the right posterior jawline near the juvéderm® volux¿ xc injection site.Ten days later, patient was treated with claritin 10mg, pepcid 1 tablet, hydrocortisone cream 1%.Symptoms are ongoing.This was the initial use of the syringe.Approximately three weeks later, patient experienced "sudden, new onset urinary incontinence [not device related] and presented to the emergency department".Patient was in a car accident 6 years prior where they experienced a l4-l5 disc slip.Treatment was not required at the time.Patient underwent an emergency laminectomy of the l4-l5 and is recovered.This relates to the second injection of juvéderm® ultra plus xc.
Event or Problem Description
Healthcare professional reported via clinical study injecting a patient with 0.7ml right temple, 0.7ml left temple, 1.3ml right cheek, 1.3ml left cheek, 2.0ml chin using juvéderm® voluma® xc, 1ml right jawline, 2ml left jawline using juvéderm® volux¿ xc, 0.7ml right nasolabial fold, 0.7ml left nasolabial fold using juvéderm® ultra plus xc, and 1ml right cheek, 1ml left cheek using skinvive¿ by juvéderm®.One month later, patient was injected with 1ml right temple, 1ml left temple, 1.4ml right mid-face, 2ml left mid-face using juvéderm® voluma® xc and 1.2ml left nasolabial fold using juvéderm® ultra plus xc.Three weeks later, patient developed non-device related urticaria and eczema in the right posterior jawline near the juvéderm® volux¿ xc injection site.Ten days later, patient was treated with claritin 10mg, pepcid 1 tablet, hydrocortisone cream 1%.Symptoms are ongoing.This was the initial use of the syringe.Approximately three weeks later, patient experienced "sudden, new onset urinary incontinence [not device related] and presented to the emergency department".Patient was in a car accident 6 years prior where they experienced a l4-l5 disc slip.Treatment was not required at the time.Patient underwent an emergency laminectomy of the l4-l5 and is recovered.This relates to the second injection of juvéderm® ultra plus xc.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: c1, c3, d1, d4, h4, h6, h10.

• Brand Name: JUVEDERM ULTRA PLUS XC TSK US
• 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: 24865840
• Report Number: 3005113652-2026-00373
• Device Sequence Number: 9239525
• Product Code: LMH
• UDI-Device Identifier: 30888628000111
• UDI-Public: (01)30888628000111(10)1002671866(11)240718(17)260618
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P050047
• 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
• Report Date (Section B): 04/24/2026

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: 06/18/2026
• Device Catalogue Number: 94155
• Device Lot Number: 1002671866
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American