BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVESS

    MDR report key: 1275523 · Received December 26, 2008

    Report

    Report Number
    MW5009441
    Event Type
    Injury
    Date Received
    December 26, 2008
    Date of Event
    October 10, 2008
    Report Date
    December 26, 2008
    Manufacturer
    ARTES MEDICAL INC
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HAD ELEVESS INJECTED AND APPROX THREE WEEKS LATER AND UP TO THIS DATE, I HAVE HAD A REALLY BAD REACTION TO THIS PRODUCT. EVERYPLACE THIS WAS INJECTED INTO MY FACE CONTINUES TO SWELL AND GETS PUSS SACKS THAT HAVE TO BE DRAINED. MY DR HAS INJECTED SOMETHING ELSE TRYING TO DISSOLVE THIS PRODUCT, BUT SO FAR THIS HAS NOT WORKED VERY WELL EITHER. AT THIS TIME, MY FACE CONTINUES TO BE SWELLED UP AND LOOKS ALL BLACK AND BLUE. I CONTINUALLY LOOK LIKE I HAVE TWO BLACK EYES AND MY EYES SWELL ALMOST SHUT AT TIMES. THIS PRODUCT NEEDS MORE RESEARCH OR NEEDS TO BE TAKEN OFF THE MARKET UNTIL PROBLEMS ARE SOLVED. I HAVE FOUND OTHER PEOPLE ONLINE SUFFERING FROM THE SAME PROBLEMS. FREQUENCY: ONE TIME ONLY. DATES OF USE: 2008. DIAGNOSIS: FACIAL FILLER. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEVESS NONE LMH ARTES MEDICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other