BEUDAMED
    FDA Adverse Event Summary report: N

    MAGNA SITE TISSUE EXPANDER

    MDR report key: 13303 · Received May 17, 1994

    Report

    Report Number
    MW1002025
    Date Received
    May 17, 1994
    Report Date
    May 9, 1994
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    LCJ
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR EXPERIENCED SWELLING OF FEET AND HANDS, MUSCLE FATIGUE, IMPLANT WRINKLES WITH INDENTATION, MIGRAINES, ULCERS, DEPRESSION, RIGHT ARM TINGLING AND NUMBNESS, NECK AND BACK PAIN, CHEST PAIN TO RIGHT SIDE OF NECK, MEMORY PROBLEMS, JOINT SWELLING, PAIN AND STIFFNESS OF FINGERS, NECK, SHOULDERS AND SHOULDER BLADE, MUSCLE FATIGUE, RASHES ON NECK AND CHEST, BREAST TENDERNESS, PAIN, ACHING, SEVERE FATIGUE, GENERAL ACHING AND STIFFNESS, COLDNESS IN HANDS, FINGERS AND FEET, WEIGHT LOSS, EAR PAIN, RIGHT IMPLANT HIGHER THAN LEFT, DIFFICULTY LYING ON STOMACH DUE TO PAIN, AND PAIN AND FAITGUE IN UPPER BODY. (SAME RPTR REFERRED TO IN 1002026.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNA SITE TISSUE EXPANDER LCJ MCGHAN MEDICAL CORP. STYLE 131 EN 4506

    Patients

    Seq Age Sex Outcome Treatment
    1 *