BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4876881 · Received June 29, 2015

    Report

    Report Number
    MW5043285
    Event Type
    Injury
    Date Received
    June 29, 2015
    Date of Event
    September 13, 2009
    Report Date
    May 4, 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). I HAVE BEEN IN UNDESCRIBABLE PAIN IN MY ABDOMEN AND PELVIC AREA FOR YEARS. I HURT IN MY HIPS AND LOWER BACK AND I QM IN A CONSTANT PAIN. I FEEL LIKE THERE IS SOMETHING MOVING INSIDE MY STOMACH AS IF I AM PREGNANT. ALL OF THIS STARTED ABOUT 2 MONTHS AFTER HAVING ESSURE PLACES. IT HAS PROGRESSIVELY GOTTEN WORSE. AT TIMES, IT IS ALMOST UNBEARABLE. MY MONTHLY CYCLE IS THE WORST. I CRAMP SO SEVERELY THAT I GET PHYSICALLY SICK, I PASS HUGE BLOOD CLOTS AND I HAVE A VERY HEAVY FLOW. CRAMPING STARTS ABOUT A WEEK BEFORE I DO AND LAST ABOUT A WEEK AFTER I STOP. I ATTRIBUTE ALL OF HIS TO ESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417743 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 39.000 YR