MAUDE Adverse Event Report: PRINGY JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN); IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	UNK JUVEDERM VOLUMA XC/LIDO
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Granuloma (1876)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional (hcp) reported injecting a patient with skinvive¿ by juvéderm®.Patient later "started getting growth on the zygoma" and "had multiple granulomas removed".Hcp notes the patient is still "actively forming them" [granulomas].Biopsy was not provided.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.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.This is a known potential adverse event addressed in the product labeling.
Additional Manufacturer Narrative
Additional, corrected, and/or changed data: b2, d1, d4, h6.
Event or Problem Description
Healthcare professional (hcp) reported injecting a patient with skinvive¿ by juvéderm®.Patient later "started getting growth on the zygoma" and "had multiple granulomas removed".Hcp notes the patient is still "actively forming them" [granulomas].Biopsy was not provided.Symptoms are ongoing.

• Brand Name: JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)
• 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 ; 8479366324
• MDR Report Key: 24794500
• Report Number: 3005113652-2026-00338
• Device Sequence Number: 18564491
• Product Code: LMH
• UDI-Device Identifier: 10840228300066
• UDI-Public: (01)10840228300066
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P110033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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: UNK JUVEDERM VOLUMA XC/LIDO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown