MAUDE Adverse Event Report: Pringy Juvederm Voluma XC 27G 2 x 1mL; implant, dermal, for aesthetic use

Catalog Number	94640DB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anxiety (2328); Skin Disorders (4543); Subcutaneous Nodule (4548)
Date of Event	05/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported they were injected with one syringe of juvéderm volbella® xc in the tear throughs, ocularis, and in the middle underneath the eye area.Patient also received 1ml of juvéderm voluma® xc into the marionette lines and 2mls of juvéderm voluma® xc into the temples.Patient noted that immediately after injection, they experienced "three big bumps in the eye area, indentation, caused disfigurement" and bilateral cystic acne on the eyelids soon after.Patient underwent two hyaluronidase injections approximately three and four weeks after the injection.Patient also received another 0.55mls of juvéderm voluma® xc into the cheeks.About another two weeks later, patient was injected with more juvéderm voluma® xc in an unspecified area that "reignited the lump and resulted in big as ever like a big mosquito bite." patient reports event has been very stressful and is being evaluated by a plastic surgeon.The healthcare professional later informed abbvie that the event was more of a "placement" and "settling" issue, noting that the left side is not settle properly and the issue was more prevalent there.Healthcare professional used pate in addition to the hyaluronidase injections and additional filler and is intending to add more filler and hyaluronidase for the events.
Additional Manufacturer Narrative
This report was impacted by emdr scheduled maintenance occurring july 22-27, 2026.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.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 Voluma XC 27G 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: 50038333
• Report Number: 3005113652-2026-00829
• Device Sequence Number: 13217875
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: (01)30888628000012(17)270924(10)1004982924
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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: 94640DB
• Device Lot Number: 1004982924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2025
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 110 LB
• Patient Race: White