BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUX 2X1ML EAME SKU1

    MDR report key: 22939063 · Received September 2, 2025

    Report

    Report Number
    3005113652-2025-00775
    Event Type
    Injury
    Date Received
    September 2, 2025
    Date of Event
    July 14, 2025
    Report Date
    September 19, 2025
    Manufacturer
    ALLERGAN (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. 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 · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: C1, D1, D4, H4, H6, H8.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH 1 CC OF JUVÉDERM® VOLUX¿ IN THE CHIN AND WITH 3 CC OF JUVÉDERM® VOLUMA® WITH LIDOCAINE IN THE MALAR, CHEEKBONE, AND PYRIFORM FOSSA. A MONTH LATER, THE PATIENT EXPERIENCED AN ¿ALLERGIC REACTION¿ WITH ¿INFLAMMATION, HARDNESS, REDNESS AND PAIN¿ AT THE CHIN, MALAR, AND RISORIO. THE PATIENT WAS TREATED WITH URBASON 40 MG, PREDNISONE 30 MG, DOXYCYCLINE, AND HYALURONIDASE. SYMTOMS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER ABBVIE COMPLAINT (B) (4) (EMDR- (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVÉDERM® VOLUX¿.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH 1 CC OF JUVÉDERM® VOLUX¿ IN THE CHIN AND WITH 3 CC OF JUVÉDERM® VOLUMA® WITH LIDOCAINE IN THE MALAR, CHEEKBONE, AND PYRIFORM FOSSA. A MONTH LATER, THE PATIENT EXPERIENCED AN ¿ALLERGIC REACTION¿ WITH ¿INFLAMMATION, HARDNESS, REDNESS AND PAIN¿ AT THE CHIN, MALAR, AND RISORIO. THE PATIENT WAS TREATED WITH URBASON 40 MG, PREDNISONE 30 MG, DOXYCYCLINE, AND HYALURONIDASE. SYMTOMS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER ABBVIE COMPLAINT (B)(6) (EMDR-101161) AND (EMDR-103829). THIS MDR IS BEING SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVÉDERM® VOLUX¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2074697 JUVEDERM VOLUX 2X1ML EAME SKU1 IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) 1001084147 10888628044852

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention