BEUDAMED
    FDA Adverse Event Summary report: N

    RADOVAN TISSUE EXPANDER, 700 CC

    MDR report key: 10627 · Received December 21, 1993

    Report

    Report Number
    MW1000195
    Date Received
    December 21, 1993
    Manufacturer
    MENTOR CORP.
    Product Code
    LCJ
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EXPANDERS WERE IMPLANTED ON 10/17/88. PROBLEMS SUSPECTED OR NOTED: CAPSULAR CONTRACTURES, POSSIBLE SILICONE LEAKAGE, ARTHRITIS SYMPTOMS IN HANDS, FEET, ELBOWS, SHOULDERS AND BACK, EXTREME FATIGUE, LEFT ARM SHAKING ON EXERTION, HAND FINGER AND FEET SWELLING, BREAST TENDERNESS, GENERAL ACHING WITH STIFFNESS, VISIBLE IMPLANT WRINKLES, IMPLANT MIGRATION, EDEMA OF HANDS AND FEET, LOSS OF STRENGTH WITH PAIN IN BACK, LEFT ARM, HAND AND LEFT SHOULDER, AND NUMBNESS IN FINGERS OF LEFT HAND. (SAME PT REFERRED TO IN 1000196 AND 1000197.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADOVAN TISSUE EXPANDER, 700 CC LCJ MENTOR CORP. 26050

    Patients

    Seq Age Sex Outcome Treatment
    1 *