MAUDE Adverse Event Report: PRINGY JUVEDERM VOLLURE XC; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	95661DB
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	06/17/2026
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.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.The event of "urinary tract infection", deemed not device related is considered an unexpected adverse drug experience.
Event or Problem Description
Healthcare professional reported that a patient was injected 1.2 ml in temples, cheeks, pre auricular and lips with juvéderm® vollure¿ xc , "patient presented with a delayed inflammatory response, had a uti, lips are hard and swollen".Later physician reported " patient started experiencing swelling of the filler and later patient was diagnosed with a uti, filler in lips was still firm ".Steroid injection, medrol dose pack, doxycycline 100mg bid for 10 days, and nitrofurantoin 100mg bid x 5 days were given as treatment.Later physician reported "more swelling in lips as well as hard bumps".Later physician reported "swelling gone in cheeks and very minimal in the lips".The event is ongoing.

• Brand Name: JUVEDERM VOLLURE XC
• 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: 25828828
• Report Number: 3005113652-2026-00751
• Device Sequence Number: 9740193
• Product Code: LMH
• UDI-Device Identifier: 10840228302817
• UDI-Public: (01)10840228302817(17)270304(10)1003950321
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/15/2026

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 Catalogue Number: 95661DB
• Device Lot Number: 1003950321
• 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: 07/01/2026
• Initial Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female