BEUDAMED
    FDA Adverse Event Other Summary report: N

    MCGHAN STYLE 168 NAMMARY IMPLANT

    MDR report key: 742689 · Received June 29, 2006

    Report

    Report Number
    MW1039552
    Event Type
    Other
    Date Received
    June 29, 2006
    Date of Event
    August 20, 2002
    Report Date
    June 28, 2006
    Manufacturer
    MCGHAN MEDICAL
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER RECEIVING MCGHAN SALINE BREAST IMPLANTS AND BEING A TOTALLY HEALTHY WOMAN, I EXPERIENCED A SEVERE AND ACUTE DECLINE IN MY HEALTH, WHICH RESULTED IN THE DIAGNOSIS OF HASHIMOTO'S AUTOIMMUNE THYROID DISEASE, AND FOLLOWING THAT, A DIAGNOSIS OF CELIAC DISEASE, WHICH HAS AN AUTOIMMUNE COMPONENT. I HAVE HAD TO CHANGE MY DIET TO A GLUTEN FREE ONE, AND AM ON THYROID MEDICATION FOR LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN STYLE 168 NAMMARY IMPLANT BREAST IMPLANTS FWM MCGHAN MEDICAL 168 KM4534
    2 MCGHAN STYLE 168 NAMMARY IMPLANT BREAST IMPLANTS FWM MCGHAN MEDICAL 168 KM 5531

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other