BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL BREAST IMPLANTS

    MDR report key: 291528 · Received July 25, 2000

    Report

    Report Number
    MW1019698
    Event Type
    Injury
    Date Received
    July 25, 2000
    Report Date
    April 3, 2000
    Manufacturer
    SURGITEK GELS
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "S/P B SUBGL PERIAREOLAR 255CC SURGITEK GELS FOR INVOLUNTARY ATROPHY. THEY ENCAPSULATED EARLY, R GREATER THAN L, AND ARE WORSENING TO THE POINT THAT THEY ARE NOW QUITE PAINFUL. THE R HAS DECREASED IN SIZE, NO H/O TRAUMA. THE PT ALSO C/O SYSTEMIC SX'S PROGRESSIVELY DISABLING TO THE POINT THAT PT FEELS THEY ARE DYING AND MUST GET IMPLANTS OUT - THESE INCLUDE MYALGIAS (+ AM STIFFNESS)/ARTHRALGIAS, PARESTHESIAS/DYSESTHESIAS, SWELLING, FATIGUE, SLEEP DISTURBANCES, ADENOPATHY, FEVERS, NIGHT SWEATS, HEADACHES, VISUAL CHANGES, MEMORY LOSS, SICCA, HAIR LOSS, RASHES, SEN SUN/COLD/ETOH, SOB/COUGH, CP, CHOKING SENSATION, DECREASED APPETITE/TASTE, ORAL/ANAL SORES, GU CHANGES, LOSS OF LIBIDO AND TM ITCHING. PT IS OTHERWISE HEALTHY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEL BREAST IMPLANTS 255CC FTR SURGITEK GELS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| S