BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5384054 · Received January 21, 2016

    Report

    Report Number
    MW5059531
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    March 18, 2008
    Report Date
    January 26, 2016
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). ABDOMINAL PAIN, BACK PAIN, HEADACHES, SHOOTING PAIN, PAIN, HEAVY BLEEDING, RASHES, SPASMS, RIGHT OVARIAN CYST, ETC.

    Description of Event or Problem · 1

    (B)(4). AS I SIT HERE IN MY BED AND THINK BACK OVER MY LIFE FROM THE DAY THE ESSURE WAS PLACED IN MY FALLOPIAN TUBES, IT HAS BEEN REALLY BEEN ROUGH! ANXIETY AND DEPRESSION IS WHAT I EXPERIENCED FIRST, FOR ABOUT THREE MONTHS I WENT THROUGH THIS, AND I WOULDN'T WISH THIS ON MY WORST ENEMY! I WAS IN AND OUT THE HOSPITAL, UNTIL THEY TRIED TO SEND ME TO PEACE RIVER! NOW I'M A CHURCH GOING GAL, AND ONE THING I BELIEVE IN IS THE FATHER, SON, AND HOLY GHOST! I TRULY BELIEVE IT WAS NOBODY BUT GOD THAT BROUGHT ME THROUGH THAT DIFFICULT TIME! THERE AFTER THE RASHES STARTED, THE BLOATING OF THE BELLY STARTED, AT TIMES LOOKING LIKE I WAS 6 MONTHS PREGNANT! IT WAS SO EMBARRASSING. PELVIC PAIN, SHARP PELVIC PAINS, REMEMBERING THAT THE RIGHT SIDE OF MY COIL WAS NOT PLACED WHERE IT NEEDED TO BE, IN THE BACK OF MY MIND KNOWING SOMETHING WAS NOT RIGHT! SEARCHING OVER THE YEARS FINDING NOTHING ON THIS EVIL CRAP THAT I'M ALLERGIC TOO! NO ONE EVER TOLD ME THAT THIS WAS NICKEL BEING PLACED IN MY BODY! I'VE BEEN ALLERGIC TO NICKEL SINCE A LITTLE GIRL! UGGGHHHH! I HATE THIS!!!! IT'S NOT RIGHT AT ALL!!! HEADACHES! SLEEPLESS NIGHTS! BACK PAINS, SPASMS, SHOOTING PAINS, HEAVY BLEEDING, OVARIAN CYST! I ONLY PRAY FOR THE REST OF WOMEN ON THE FACE OF THIS EARTH, THAT GOD BE WITH THEM! LEAD AND GUIDE THEM IN THE RIGHT DIRECTION WHEN IT COMES TO PROTECTING THEMSELVES! GOD HAS THE LAST SAY SO IN THIS MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41964 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 28.000 YR Hospitalization