BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUX 2X1ML EAME SKU1

    MDR report key: 23028518 · Received September 11, 2025

    Report

    Report Number
    3005113652-2025-00811
    Event Type
    Injury
    Date Received
    September 11, 2025
    Date of Event
    July 31, 2025
    Report Date
    September 11, 2025
    Manufacturer
    PRINGY
    Product Code
    LMH
    UDI-DI
    10888628044852
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE MAXILLARY RIDGE, CHIN, MALAR, AND CHEEKBONES WITH 4 CC OF JUVÉDERM® VOLUX¿. THREE MONTHS LATER, THE PATIENT EXPERIENCED ¿LATE ONSET INFLAMMATORY NODULES.¿ THE PATIENT WAS TREATED WITH URBASON 40 MG, PREDNISONE 30 MG, HYALURONIDASE, AND DOXYCYCLINE. EVENT IS ONGOING. THIS FILE CAPTURED LOT 1000799061. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6); (EMDR-102753). THIS EMDR IS BEING SUBMITTED FOR LOT 1000799061.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2675968 JUVEDERM VOLUX 2X1ML EAME SKU1 IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY 1000799061 10888628044852

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention