MAUDE Adverse Event Report: UNKNOWN ALLERGAN JUVEDERM VOLLURE XC 2X1 ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number	95661
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nodule (4551)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A patient reported being injected with one syringe of juvéderm vollure¿ xc in the marionette lines.The patient experienced ¿late onset nodules which are really present and noticeable, bumps, bruising, hardness, throbs and sensations, itchy one spot, and ripples on the side of mouth." no treatment has been provided.The symptoms are ongoing.

• Brand Name: JUVEDERM VOLLURE XC 2X1 ML
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): UNKNOWN ALLERGAN; 900 parkway global park zona f; la aurora de heredia ; CS
• Manufacturer (Section G): UNKNOWN ALLERGAN; 900 parkway global park zona f; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 22338498
• Report Number: 9617229-2025-10660
• Device Sequence Number: 9160545
• Product Code: LMH
• UDI-Device Identifier: 10888628034471
• UDI-Public: (01)10888628034471
• Combination Product (Y/N): Y
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2025

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: 95661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 06/26/2025
• 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
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White