BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC 27G 2 X 1ML

    MDR report key: 3893854 · Received June 12, 2014

    Report

    Report Number
    3005113652-2014-00252
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(4) 2014. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF NODULES AND SWELLING 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 2 MONTHS AFTER INJECTION WITH 2 SYRINGES OF JUVEDERM VOLUMA XC IN THE CHEEKS AND CHIN THE PATIENT DEVELOPED "DEEP NODULES" AT THE INJECTION SITES AND "SWELLING UNDER [THE] LEFT EYE". THE NODULES WERE DISCOVERED BY THE PATIENT WHEN WASHING THEIR FACE. THE PATIENT WAS TREATED WITH CEPHALEXIN, CLINDAMYCIN, AND A MEDROL DOSEPAK. THE NODULES DID GET SMALLER WITH THE MEDROL DOSEPAK BUT STARTED RECURRING SO THE PATIENT WAS ADDITIONALLY PRESCRIBED PREDNISONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348877 JUVEDERM VOLUMA XC 27G 2 X 1ML LMH ALLERGAN NA VB20A30188

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR