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	Inflammation (1932)
Date of Event	09/23/2025
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.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 reported a patient was injected with 2mls of juvéderm® volux¿ xc into the bilateral gonial angle and pre auricular space.Patient also injected with 0.5ccs of juvéderm® ultra into the lips.About a month after injection, patient began experiencing swelling and pain in the right jaw.Patient reported difficulty biting into harder food items.Patient was prescribed prednisone 40mg for three weeks.Symptoms reportedly dissipated about a month later, but ultimately returned within two weeks.Two days after the return of symptoms, the area was dissolved with 150u hylenex and patient was prescribed another 10 days of prednisone 40mg.2 weeks later, patient denied any present symptoms.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: following fields for inital (b)(4) should have been captured as follows.Become aware date: 12/01/2025, due date: (b)(6) 2025, and g3 date received by mfg: 12/01/2025.
Event or Problem Description
Healthcare professional reported a patient was injected with 2mls of juvéderm® volux¿ xc into the bilateral gonial angle and pre auricular space.Patient also injected with 0.5ccs of juvéderm® ultra into the lips.About a month after injection, patient began experiencing swelling and pain in the right jaw.Patient reported difficulty biting into harder food items.Patient was prescribed prednisone 40mg for three weeks.Symptoms reportedly dissipated about a month later, but ultimately returned within two weeks.Two days after the return of symptoms, the area was dissolved with 150u hylenex and patient was prescribed another 10 days of prednisone 40mg.2 weeks later, patient denied any present symptoms.
Event or Problem Description
The hcp additionally reported that six months after, the patient denied any pain and swelling, the swelling returned at the right gonial angle.The patient was treated with doxycycline 100mg x 4 weeks.The symptoms are ongoing.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: a4, b5, h6.

• 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: 23779854
• Report Number: 3005113652-2025-01127
• Device Sequence Number: 18661079
• Product Code: LMH
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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,Followup
• Report Date (Section B): 07/02/2026

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: 09/11/2025
• Device Catalogue Number: 20073770
• Device Lot Number: 1000713755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 06/29/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 12/11/2025; 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2023
• 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: 37 YR
• Patient Sex: Female
• Patient Weight: 145 LB
• Patient Race: White