MAUDE Adverse Event Report: PRINGY JUVEDERM VOLUX XC 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	20073770
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional (hcp) reported injecting a patient with 3 syringes of juvéderm® volux¿ xc to the jawline as well as juvéderm® voluma® xc and an unspecified juvéderm® ultra product.Patient developed swelling and pain that "comes and goes" at the injection site of juvéderm® volux¿ xc.Hcp noted nodules are more present on the left side than the right side and appear to be roughly 2.5cm x 0.5cm.Symptoms are ongoing.This relates to juvéderm® volux¿ xc.
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.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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional (hcp) reported injecting a patient with 3 syringes of juvéderm® volux¿ xc to the jawline as well as 1 syringe of juvéderm® voluma® xc and 1 syringe of juvéderm® ultra xc.Patient developed swelling and pain that "comes and goes" at the injection site of juvéderm® volux¿ xc (along the post jowl to the mandibular angle bilateral).
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: a2, a5, a6, b5, d6a, h4, h8.

• Brand Name: JUVEDERM VOLUX XC 2 X 1ML
• 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: 24818122
• Report Number: 3005113652-2026-00354
• Device Sequence Number: 12264914
• Product Code: LMH
• UDI-Device Identifier: 10840228300073
• UDI-Public: (01)10840228300073(10)1000752347(11)231024(17)250924
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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 Expiration Date: 09/24/2025
• Device Catalogue Number: 20073770
• Device Lot Number: 1000752347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/06/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2023
• 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
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White