BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC 27G 2X 1ML

    MDR report key: 4172792 · Received October 10, 2014

    Report

    Report Number
    3005113652-2014-00546
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    May 15, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO FROM THE REPORTER REGARDING EVENT HAS BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE EVENTS OF "DEFORMITY ON THE CHEEKS, ABSCESS AND REDNESS" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED APPROXIMATELY 1 MONTH AFTER INJECTION WITH 2 SYRINGES OF JUVEDERM VOLUMA XC IN THE CHEEKS, THE PT DEVELOPED "DEFORMITY ON THE CHEEKS, ABSCESS, AND REDNESS" AT THE INJECTION SITES. VITRASE WAS ADMINISTERED AS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642590 JUVEDERM VOLUMA XC 27G 2X 1ML LMH ALLERGAN NA VB20A40007

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention