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	Abscess (1690); Medical Device Site Inflammation (4929)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional (hcp) reported injecting a patient with 2 syringes of juvéderm volux¿ xc in the left cheek, marionette lines, zygoma, and right cheek indentation.The patient concomitantly takes ¿lamtetac 400 and copazlam 15q.¿ two weeks post injections, the patient experienced ¿swelling, hot to touch, patient¿s body is rejecting the product in the cheeks.That same day the patient had a ¿bacteria culture¿ performed, which was negative.Also, that same day, the patient was treated with bactrim.Two days later, the patient was also treated with hylenex®.The hcp additionally reported "patient developed sterile abscess only where the syringe injected on the left side of the face.Significant amount of purulent xxxx drained and still is xxx.¿ symptoms are ongoing.
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 discarded.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 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.

• 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: 25437198
• Report Number: 3005113652-2026-00573
• Device Sequence Number: 10095815
• Product Code: LMH
• UDI-Device Identifier: 10840228302831
• UDI-Public: (01)10840228302831(17)271003(10)1005088606
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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: 20074128
• Device Lot Number: 1005088606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic