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 Code	Abscess (1690)
Date of Event	07/16/2026
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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
A healthcare professional reported that a patient was injected into the chin using an unknown juvéderm® volux¿ xc.3 to 4 weeks after the injection the patient started to feel tender in the chin.The chin became very swollen, and the healthcare professional was concerned about a potential abscess.The patient was referred out to a dermatologist who performed an incision and drainage, then used a pressure bandage.There was a lot of puss drained, it had cultured, and the patient is currently on 2 antibiotics.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: b5, c1, c3, d1, d4, d6a, h4, h6.A review of the device history record has been completed.No deviations or non-conformances noted.
Event or Problem Description
Additionally, the healthcare professional reported that the patient was injected with 1cc of juvéderm® ultra xc for lip rejuvenation, and 1cc of juvéderm® volux¿ xc to the chin (0.8cc) and bilateral anterior jawline (0.2cc) for jawline definition delivered using needle in supraperiosteal plane.The following month the patient complained of tender bumps on the chin, without symptoms in lips, the patient-initiated otc ibuprofen 600mg tid.Later that month the patient brought in for appointment to assess tender nodule that was erythematous, swollen and was initated on 100mg doxycycline bid x 2 weeks while continuing otc ibuprofen 600mg tid with slight improvement in tenderness.A nodule was noted so the doxycycline was stopped and clarithromycin 500mg bid and ciprofloxacin 500mg bid were initiated for suspected cutaneous infection.Lastly, the patient was referred to a dermatologist where i&d performed and cultured.The doxycycline was reinstated in conjunction with other two antibiotics to continue until follow up with dermatologist in 2 weeks.The patient is currently on antibiotics without full resolution; treating the provider has considered dissolving with hyaluronidase and possibly initiating corticosteroids.

• 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 ; +1(847)936-6324
• MDR Report Key: 50071517
• Report Number: 3005113652-2026-00853
• Device Sequence Number: 21433717
• Product Code: LMH
• UDI-Device Identifier: 10840228302831
• UDI-Public: (01)10840228302831(17)270411(10)1004067529
• Combination Product (Y/N): Y
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2026

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: 1004067529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/27/2026
• Supplement Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2025
• 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 Sex: Unknown