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

Catalog Number	94640
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported a patient who was injected with 7 ml of juvéderm® voluma¿ xc in the cheek, and chin area.The patient was also injected with 2 ml of juvéderm® volux¿ xc in the cheek and injection sites and jawline at gonial angle 0.5 ml per side.Post injection the patient contacted the hcp regarding the right side between their lips and chin that was very sore after the injection.The hcp reassured the patient that it was likely filler, and it needed to settle.The hcp instructed them not to press or manipulate the filler and that it could take few weeks to settle.Recently the lump on the right side of their chin is now swollen and painful.The hcp requested the patient come for a visit.The hcp prescribed the patient doxycycline for upper respiratory infection.Also were treated with doxycycline which they prescribed for seven days and prescribed the patient to take more prednisone 60mg for 3 days, 40mg for 3 days, 20 mg for 3 days and 10 mg for 3 days.
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.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.The event of "upper respiratory infection", deemed not device related is considered an unexpected adverse drug experience.

• 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: 50116898
• Report Number: 3005113652-2026-00872
• Device Sequence Number: 10076735
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: (01)30888628000012(17)271231(10)1005570305
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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
• Report Date (Section B): 08/13/2026

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: 94640
• Device Lot Number: 1005570305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 07/23/2026
• Supplement Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2026
• 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: 63 YR
• Patient Sex: Female