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	Inflammation (1932)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional (hcp) reported injecting a patient with juvéderm volux¿ xc in the jawline area.About a week and a half later, the patient ¿reported redness and irritation in the area of injection.¿ after discussion, the patient did say that they applied topical skincare products to the face shortly after being injected.They also had a deep teeth cleaning 2 days after the filler injection.The patient was treated with hylanex ® twice three days apart.The patient was also given antibiotics.The area of redness and irritation has been showing improvement.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 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.

• 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: 50756146
• Report Number: 3005113652-2026-01065
• Device Sequence Number: 9551014
• Product Code: LMH
• UDI-Device Identifier: 10840228302831
• UDI-Public: (01)10840228302831(17)270519(10)1004362555
• 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): 09/18/2026

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: 1004362555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/09/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/14/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2025
• 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: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 150 LB
• Patient Race: White