BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC 27G 2X 1ML

    MDR report key: 3834605 · Received May 2, 2014

    Report

    Report Number
    3005113652-2014-00173
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    March 11, 2014
    Report Date
    April 8, 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

    FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADD'L INFO IS AVAILABLE AT THIS TIME. THE EVENTS OF SWELLING AND "SKIN THAT IS WARM TO THE TOUCH" 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 ONE WEEK AFTER INJECTION WITH JUVEDERM VOLUMA XC IN THE CHEEKS THE PT EXPERIENCED "SWELLING AND WARM TO THE TOUCH" AT THE INJECTION SITE. PT WAS PRESCRIBED KEFLEX. SYMPTOMS HAVE NOT YET RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265269 JUVEDERM VOLUMA XC 27G 2X 1ML LMH ALLERGAN NA VB20A30421

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention GENERIC ZOLOFT