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

Catalog Number	20074128
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932)
Date of Event	05/03/2026
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.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
A healthcare professional (hcp) reported that a patient was injected into the jawline with 1cc of juvéderm® volux¿ xc a week later the patient was presented with right chin redness, swollen, tenderness and it was warm to the touch.Since the patient is also a healthcare professional, they prescribed themselves augmentin and prednisone when the symptoms 1st appeared.Healthcare professional additionally reported that a patient was injected with 1 cc of juvéderm® volux¿ xc into the supra periosteum.The patient developed erythema and 2 induration and warm to touch noted to deposit site of filler on the right lateral mentom.The hcp stated that there is a differential by acute infection vs.Early onset inflammatory reaction.The patient self-prescribed themselves of augmentin and prednisone.Also, the hcp provided rx for clarithromycin 500 mg, bid for 2 weeks.The symptoms have not been fully resolved.

• Brand Name: JUVEDERM VOLUX XC 2 X 1ML SAMPLE
• 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: 25150852
• Report Number: 3005113652-2026-00464
• Device Sequence Number: 13451093
• Product Code: LMH
• UDI-Device Identifier: 10840228302831
• UDI-Public: (01)10840228302831(17)260820(10)1002671805
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P050047
• 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 Practitioner
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: 08/20/2026
• Device Catalogue Number: 20074128
• Device Lot Number: 1002671805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2024
• 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: 40 YR
• Patient Sex: Female