BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE-FILL MAMMARY IMPLANT

    MDR report key: 15180 · Received August 10, 1994

    Report

    Report Number
    MW1003067
    Event Type
    Injury
    Date Received
    August 10, 1994
    Date of Event
    November 20, 1991
    Report Date
    August 7, 1994
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD SILICONE IMPLANTS REPLACED WITH SALINE BREAST IMPLANTS. A FEW MONTHS AFTER SURGERY, SYMPTOMS FROM THE SILICONE IMPLANTS HAD NOT GONE AWAY AND CONTINUED TO GET WORSE. RASHES ON FACE AND NECK, HAIR LOSS, EXTREME FATIGUE, MUSCLE WEAKNESS, BLOATING, CHEMICAL SENSITIVITIES, FOOD ALLERGIES, HOT FLASHES, WEAK BACK, NUMBNESS IN LEG, FOOT, ARMS AND HANDS, MEMORY LOSS, CONCENTRATION PROBLEMS. EYE SIGHT VERY BLURRED AND WEAK, NIPPLE NUMBNESS. THE SAME RPTR IS REFERRED TO IN 1003068.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE-FILL MAMMARY IMPLANT Implant SALINE IMPLANT FWM MCGHAN MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention| S