BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC 27G 2 X 1ML

    MDR report key: 3925622 · Received June 17, 2014

    Report

    Report Number
    3005113652-2014-00271
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 23, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENTS OF "SWOLLEN", "FIRM AREAS", "HARD LESIONS", "LUMPS", AND "NODULES" 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

    HEALTHCARE PROFESSIONAL REPORTED APPROXIMATELY 1.5 MONTHS AFTER INJECTION WITH JUVEDERM VOLUMA XC IN THE AREA "LATERAL TO THE ORAL COMMISSURES" THE PATIENT DEVELOPED SWELLING, FIRM AREAS, LUMPS, AND HARD LESIONS AT THE INJECTION SITES AS WELL AS THE "MALAR CHEEKS, BUCCAL CHEEKS, RIGHT ORAL COMMISSURES, JAW LINE, CHEEK BONE, AND TEMPLE AREA. " THE PATIENT WAS PRESCRIBED A MEDROL DOSEPAK AND A "Z-PACK." PER THE HEALTHCARE PROFESSIONAL, THE SYMPTOMS WOULD DISAPPEAR BUT REOCCUR WITHIN 24 HOURS OF DISCONTINUING THE MEDICATIONS. THE PATIENT'S SYMPTOMS "ARE GETTING WORSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356444 JUVEDERM VOLUMA XC 27G 2 X 1ML LMH ALLERGAN NA VB20A30188

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention