BEUDAMED
    FDA Adverse Event Summary report: N

    GEL BREAST IMPLANT, 280 CC

    MDR report key: 12412 · Received March 30, 1994

    Report

    Report Number
    MW1001334
    Date Received
    March 30, 1994
    Report Date
    March 24, 1994
    Manufacturer
    MCGHAN MEDICAL
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED THE FOLLOWING PROBLEMS: PREGNANCY AFTER IMPLANTS, SPIDER VEINS IN LEGS, SHOULDER PROBLEMS, DEPRESSION, CAPSULAR CONTRACTURES, NECK AND ARM PAIN, ARTHRITIS SYMPTOMS, MUSCLE FATIGUE, SWELLING OF HANDS AND FINGERS, FATIGUE, LEFT SIDE AND SHOULDER NUMBNESS, SWOLLEN NECK GLANDS, WEIGHT LOSS, COLD HANDS AND FEET, AND ONE IMPLANT HIGHER THAN THE OTHER. (ALSO SEE 1001333.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEL BREAST IMPLANT, 280 CC FTR MCGHAN MEDICAL STYLE 40 EF2377, EF2366

    Patients

    Seq Age Sex Outcome Treatment
    1 *