BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4882349 · Received July 1, 2015

    Report

    Report Number
    MW5043339
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    February 1, 2005
    Report Date
    May 13, 2015
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). FIRST OF ALL AFTER ESSURE PLACEMENT I GOT PREGNANT WITH MY 5TH CHILD WHO HAS HAD ALLERGIES AND SEIZURES FROM DAY ONE. NONE OF MY OTHER CHILDREN HAVE SEIZURES. THERE IS A CYST THAT IS IN HIS HEAD THAT HAS BEEN THERE FOR AS LONG AS I KNOW, SINCE HIS FIRST MRI , THAT IS STILL IN THE SAME LOCATION NOW SAME SIZE FOR LAST 7 YEARS. MY SON HAS BEEN ON MEDICATION FOR THIS LONG. I' M NOT SURE IF ONE OF THE COILS MIGRATED INTO HIM AS A FETUS. I MYSELF HAVE CONSTANT CRAMPING AND BLOATING, WITH THE WEIGHT GAIN IN MY ABDOMINAL AREA. I BELIEVE THAT ESSURE HAS CAUSED ME TO GO INTO EARLY MENOPAUSE. I HAVE JOINT PAIN IN ALL OF MY JOINTS THAT STARTED AFTER ESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428476 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 47.000 YR