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	Abscess (1690)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported that a patient was injected with juvéderm® volux¿ xc.The patient experienced an "abscess.¿ event status was unknown.
Event or Problem Description
Additionally, the healthcare professional reported injected in the jawline with 0.5 ml of juvéderm® volux¿ xc.Ten days later, the patient was ¿swollen, tender¿ at the injection site, specified as ¿right jawline cheek¿ and was treated with doxycycline and augmentin.Two days later, the patient was treated with steroids and ibuprofen.Four days later, the patient was treated with hospital antibiotics, and a ct was performed that showed ¿abscess in right masseter muscle.¿ the next day, an ultrasound was performed that showed ¿solid.¿ the next day, an mri was performed that showed ¿abscess in right masseter muscle, edematous parotid gland.¿ the following day, the patient was treated with an ir drain abscess, 2 ml removed.The patient was discharged from hospital 2 days later and reported an upcoming appointment with an infectious disease doctor and a dermatologist to dissolve the filler.The patient reported improvement but still small golf ball-sized swelling and pain to the mouth when brushing teeth.
Additional Manufacturer Narrative
Clarification to e.1.Address 1: (b)(6).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.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.This is a known potential adverse event addressed in the product labeling.
Additional Manufacturer Narrative
Clarification to e.1.Address 1: (b)(6).Additional, corrected, and/or changed data: a2, a3a, a6, b2, b3, b5, b6, c1, d4, d6a, e1, h4, and 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 ; +1(847)936-6324
• MDR Report Key: 50181522
• Report Number: 3005113652-2026-00885
• Device Sequence Number: 8243253
• Product Code: LMH
• UDI-Device Identifier: 10840228300073
• UDI-Public: (01)10840228300073(17)271003(10)1005088604
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• 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,Followup
• Report Date (Section B): 09/29/2026

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: 20073770
• Device Lot Number: 1005088604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/04/2026
• Supplement Date Received by Manufacturer: Not provided; 09/24/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 08/21/2026; 09/29/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Race: White