BEUDAMED
    FDA Adverse Event Summary report: N

    RADOVAN TISSUE EXPANDER

    MDR report key: 13300 · Received May 17, 1994

    Report

    Report Number
    MW1002023
    Date Received
    May 17, 1994
    Report Date
    April 30, 1994
    Manufacturer
    MENTOR CORP.
    Product Code
    LCJ
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR EXPERIENCED PNEUMONIA, ARTHRITIS, LEFT ARM ARTHRITIS SYMPTOMS, PSORIASIS, JOINT SWELLING, PAIN, STIFFNESS, MUSCLE FATIGUE, HAND AND FINGER SWELLING, FATIGUE, GENERAL ACHING AND STIFFNESS, HAIR LOSS, INCORRECT IMPLANT SIZE, MALPOSITION OF IMPLANTS UNDER ARM, QUIVERING LEG WHEN GETTING UP, FLU, UPPER RESPIRATORY INFECTION, DIFFICULTY SLEEPING, DEPRESSION, ANXIETY, DIZZINESS, SWEATING, WEIGHT LOSS, CHEST PAIN, HYPERTENSION, HYPERCHOLESTEROLEMIA, BREAST TENDERNESS, PROBLEMS LIFTING ARM, WEAKNESS AND PAIN IN LEGS, STIFF SHOULDER, EDEMA IN RIGHT FOOT AND ANKLE, AND BRONCHITIS. (SAME RPTR REFERRED TO IN 1002024.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADOVAN TISSUE EXPANDER LCJ MENTOR CORP. STYLE 7000 ROUND TE: 27626

    Patients

    Seq Age Sex Outcome Treatment
    1 *