BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE GEL BREAST IMPLANT

    MDR report key: 165593 · Received April 21, 1998

    Report

    Report Number
    MW1013670
    Event Type
    Injury
    Date Received
    April 21, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP. HEYER SCHULTE
    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

    A 50 YR OLD WHITE FEMALE STATUS POST SUBGLANDULAR INFRAMAMMARY, 240CC, HEYER SCHULTE GELS PLACED FOR AUGMENTATION ON 05-13-75. PT STATES THE RIGHT HAS DECREASED IN SIZE OVER THE YRS. THE LEFT HAS ALWAYS BEEN HARDER AND MORE PAINFUL WITH INCREASED PAIN. NO HISTORY OF TRAUMA. ARTHRALGIAS, (MORNING STIFFNESS)/MYALGIAS, DYESTHESIAS/PARESTHESIAS, SLEEP DISTURBANCES, NIGHT SWEATS, HEADACHES, TEMPOROMANDIBULAR JOINT DISEASE, VISUAL CHANGES, ORTHOSTATIC DIZZINESS, MEMORY LOSS, SICCA, BROW LOSS, ORAL SORES, RASHES, SENSITIVITY TO SUN/COLD, SHORTNESS OF BREATH/CHEST PAIN/COSTOCHONDRITIS, INCREASED CHOLESTEROL, WEIGHT GAIN, GASTROINTESTINAL/GENITOURINARY PROBLEMS, AND EASY BRUISING, DYSPAREUNIA. RIGHT RUPTURED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE GEL BREAST IMPLANT Implant 240CC GEL FTR BAXTER HEALTHCARE CORP. HEYER SCHULTE * "36" STAMPED ON BACK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| S