BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4113672 · Received September 24, 2014

    Report

    Report Number
    MW5038268
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    July 24, 2014
    Report Date
    September 21, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    #MEDWATCHER #(B)(4). HIGH ANXIETY BEGAN RIGHT AFTER I HAD THE IMPLANT IN. I JUST PUT IT OFF AS HAVING TWO BOYS. THAT WAS UNTIL I HAD TO GET PUT ON MEDICINE BC OF SEVERE PANIC ATTACKS. ON (B)(6) I GOT MY SECOND PERIOD IN ONE MONTH. THEY WERE ONLY 18 DAYS APART. AFTER THE SECOND PERIOD ENDED I BEGAN SWELLING IN MY ABDOMEN, SEVERE CRAMPING AND FATIGUE. I AM (B)(6) YEARS OLD AND AM IN NEED OF A HYSTERECTOMY. I SHOULDN'T BE THIS TIRED. THE CRAMPING AND FATIGUE HAS TAKEN OVER MY LIFE TO THE POINT I DON'T WANT TO GET OUT OF BED IN THE MORNING. I WANT MY LIFE BACK. I AM A SKINNY GIRL AND LOOK LIKE I AM 4 MONTHS PREGNANT. MY BLOOD LEVELS ARE LOW DUE TO THE ONCOMING PERIODS EVERY 18 DAYS APART. SEX IS EXTREMELY PAINFUL, BUT MY HUSBAND UNDERSTANDS UNLIKE SOME OF THE OTHERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595322 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 26.000 YR