MAUDE Adverse Event Report: PRINGY JUVEDERM VOLLURE XC 2X1 ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	95661
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	02/10/2026
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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported a patient injected in the lips with 1ml of juvéderm® volbella¿ xc, in the smile line with 1ml of juvéderm®vollure¿ xc and in the jawline, checks and prejowl sulcus with 1ml of juvéderm® voluma¿ xc present "delayed onset nodules affecting right lower lip, and bilateral jawline".Later healthcare professional reported approximately two months after injection patient had a lip touch up and "patient noticed swelling of the right side lower lip" and six days later "left sided jawline inflammation" and then "swelling progressed to the right side of the jawline with nodule formation", healthcare professional also indicate "bilateral jawline swelling with nodule formation and lower lip swelling with nodule formation" and "inflammation of lips and filler migration".Patient was pretreatment with topical ointment naxexis ointment and posttreatment with ice and for the symptoms patient was treatment with doxycycline 100mg twice a day for 14days.Event is ongoing.This record is for the product juvéderm®vollure¿ xc.
Event or Problem Description
A month after injection patient had a lip touch up with 1 ml of juvéderm® volbella¿ xc and approximately three mounts after original injection.Later healthcare professional reported that filler migration was just in lips.Patient report significant reduction in nodules.Event is ongoing.
Additional Manufacturer Narrative
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.

• Brand Name: JUVEDERM VOLLURE 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 ; 8479366324
• MDR Report Key: 24507846
• Report Number: 3005113652-2026-00211
• Device Sequence Number: 18670828
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: (01)10888628034471(10)1003364044(11)250119(17)261219
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 95661
• Device Lot Number: 1003364044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2025
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female