MAUDE Adverse Event Report: Pringy JUVEDERM VOLBELLA XC 2 x 1mL 32G; implant, dermal, for aesthetic use

Catalog Number	96181
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Subcutaneous Nodule (4548)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported being injected with an unspecified juvéderm®.The next year, the patient experienced ¿bumps¿ all over the face, under the lips, and sides of the cheeks¿ that were described as ¿pretty thick¿ on the upper lip, some on the jawline, and on the cheekbone, the size of ¿maybe a dime or nickel.¿ a ct scan confirmed the nodules.The patient as treated with amoxicillin that they had just completed, and steroids were considered next.The filler looked like it was ¿protruding out the sides of the face.¿ event was ongoing.Additionally, the healthcare professional reported that the patient was injected in the cheek, lips, and jawline with 1 cc of juvéderm® voluma¿ xc, 1 cc of juvéderm® volbella¿ xc, and 1 cc of juvéderm® volux¿ xc.The event occurred at the injection sites.The amoxicillin treatment was not given by the injector, and no specifics could be given for it.Two months post-onset, the patient was treated with keflex 500 mg po bid.Two weeks later, the patient was treated with a medrol dosepak to be taken as directed and hylenex.This file captured the juvéderm® volbella¿ xc.
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 completed.No deviations or non-conformances noted.This is a known potential adverse event addressed in the product labeling.This report was impacted by emdr scheduled maintenance occurring (b)(6) 2026.

• Brand Name: JUVEDERM VOLBELLA XC 2 x 1mL 32G
• 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: 50009089
• Report Number: 3005113652-2026-00806
• Device Sequence Number: 8411586
• Product Code: LMH
• UDI-Device Identifier: 10888628043541
• UDI-Public: (01)10888628043541(17)260921(10)1002893503
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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: 09/21/2026
• Device Catalogue Number: 96181
• Device Lot Number: 1002893503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2024
• 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: 73 YR
• Patient Sex: Female