BEUDAMED
    FDA Adverse Event Summary report: N

    SALINE INFLATABLE ROUND BREAST IMPLANT, 425 AND 25 CC

    MDR report key: 10632 · Received December 21, 1993

    Report

    Report Number
    MW1000201
    Date Received
    December 21, 1993
    Manufacturer
    MENTOR CORP.
    Product Code
    FWM
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD THE IMPLANTS IMPLANTED ON 8/14/87 TO REPLACE GEL IMPLANTS. 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, 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 1000200.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE INFLATABLE ROUND BREAST IMPLANT, 425 AND 25 CC FWM MENTOR CORP. 188 9002

    Patients

    Seq Age Sex Outcome Treatment
    1 *