BEUDAMED
    FDA Adverse Event Summary report: N

    ARTEFILL

    MDR report key: 3724121 · Received March 31, 2014

    Report

    Report Number
    MW5035420
    Date Received
    March 31, 2014
    Date of Event
    November 19, 2012
    Report Date
    March 29, 2014
    Manufacturer
    ARTES MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INJECTED WITH ARTEFILL TO CORRECT MARIONETTE LINES. WITHIN ONE MONTH THERE WAS NO SIGN OF IMPROVEMENT AND I BEGAN HAVING CONTINUING PROBLEMS. OPENING MY MOUTH WIDE IS DIFFICULT AND WHEN I YAWN IT FEELS LIKE SOMETHING IS PULLING OR TEARING. I HAVE A WEIRD SENSATION THAT FEELS LIKE A CONSTANT NUMBNESS. I HAVE CLUMPS OF PRODUCT WHERE THE ARTEFILL IS PLACED AND SUFFERED WITH A PAINFUL INFECTION AND UNABLE TO EAT PROPERLY. I LOST 10 LBS. I HAVE SUFFERED MUCH EMBARRASSMENT AS THE CONTINUING PROBLEMS HAVE NOT ALLOWED FOR ME TO HAVE ANY OTHER INJECTABLES OR COSMETIC IMPROVEMENTS AND THIS HAS CAUSED ME EXTREME LOSS OF CONFIDENCE AND LOW SELF ESTEEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189773 ARTEFILL ARTEFILL LMH ARTES MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other