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	04/21/2025
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 completed.No deviations or non-conformance's noted.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported injecting a patient in the nasolabial folds and oral commissures with 1.4 ml of juvéderm® vollure¿ xc.Two months later, the patient was injected in the nasolabial folds, marionette lines, and lips with 1.1 ml of juvéderm® vollure¿ xc and in the vertical lip lines with 0.5 ml of skinvive¿ by juvéderm®.A month later, the patient reported ¿swelling and pain¿ and was treated with hylenex 50 units.Four days later, the patient reported ¿increased nodules,¿ unilateral to the left side of the nasolabial folds and top lip.Cmac treatment was initiated with prednisone 60 mg x 4 days to taper to 20 mg every 4 days until finished.Three days later, the patient experienced ¿bilateral nodules¿ in the marionette lines, nasolabial folds, top lip and super lip area that was ¿swollen and painful.¿ the next day, the patient received a second hylenex treatment with 300 units and continued to take prednisone.A week later, the patient was additionally treated with hylenex and prednisone.The patient later disclosed that they had been receiving allergy shots every 2 weeks for severe dog allergies and their last shot was 3 days prior to onset.Event is ongoing.This file captures the initial juvéderm® vollure¿ xc.This is the same event and the same patient reported under patient identifier: (b)(6) (emdr-(b)(4) and (b)(6) (emdr-(b)(4).This emdr is being submitted for the initial juvéderm® vollure¿ xc.

• 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: 22099837
• Report Number: 3005113652-2025-00493
• Device Sequence Number: 8391970
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: (01)10888628034471(10)1000749867(11)231023(17)250923
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

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: 09/23/2025
• Device Catalogue Number: 95661
• Device Lot Number: 1000749867
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2023
• 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: 59 YR
• Patient Sex: Female
• Patient Race: White