BEUDAMED
    FDA Adverse Event Summary report: N

    HEYER-SCHULTE ROUND GEL INFLATABLE, 425 CC

    MDR report key: 10631 · Received December 21, 1993

    Report

    Report Number
    MW1000200
    Date Received
    December 21, 1993
    Manufacturer
    V. MUELLER DIV. BAXTER HEALTHCARE CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD IMPLANTS IMPLANTED ON 4/10/84. PROBLEMS NOTED: PAINFUL IMPLANTS WITH BREAST TENDERNESS, MIGRAINES, ARTHRITIS WITH SYMPTOMS, JOINT SWELLING, PAIN AND STIFFNESS IN HANDS AND FINGERS. MUSCLE FATIGUE, RASHES AROUND BREASTS, FATIGUE, GENERAL ACHING AND STIFFNESS, SWOLLEN GLANDS IN THROAT, COLDNESS AND PAIN IN EXTREMITIES, WEIGHT LOSS, MALPOSITION OF IMPLANTS, VISIBLE IMPLANT WRINKLES, IMPLANT MIGRATION, NOISES IN IMPLANTS, PAIN IN WEARING BRAS, BREAST SCARS AND BLOOD IN URINE. (SAME RPTR REFERRED TO IN 1000201.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEYER-SCHULTE ROUND GEL INFLATABLE, 425 CC FTR V. MUELLER DIV. BAXTER HEALTHCARE CORP. 7000 7744670

    Patients

    Seq Age Sex Outcome Treatment
    1 *