BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC/LIDO (VOLUME UNK)

    MDR report key: 3850571 · Received May 22, 2014

    Report

    Report Number
    3005113652-2014-00223
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALLERGAN IS UNABLE TO CONFIRM WITH THE HEALTHCARE PROFESSIONAL, THEREFORE, ADDITIONAL EVENT, PRODUCT, OR PATIENT DETAILS ARE NOT ATTAINABLE. THE EVENTS OF "LEFT CHEEK LOOKED LIKE IT HAD A GOLF BALL THERE", "REAL SORE", "SWOLLEN AND VERY RED" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 1

    PATIENT REPORTED THE MORNING AFTER INJECTION WITH JUVEDERM VOLUMA XC IN THE CHEEKS THEY OBSERVED THAT THEIR "LEFT CHEEK LOOKED LIKE IT HAD A GOLF BALL THERE" WHICH WAS "REAL SORE TO THE TOUCH". THE FOLLOWING DAY THE PATIENT STATED "WHEN I GOT UP MY ENTIRE LEFT SIDE OF MY FACE WAS SWOLLEN AND VERY RED" INCLUDING THE "LEFT EYE AND NECK". PATIENT WAS TREATED WITH ICE, SULFAMETHOXAZOLE, AND SINECCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306891 JUVEDERM VOLUMA XC/LIDO (VOLUME UNK) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention