BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3875283 · Received June 16, 2014

    Report

    Report Number
    MW5036613
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HI I AM (B)(6) YEARS OLD AND HAVE A FACTOR 5 CLOTTING DISORDER SO ESSURE SEEMED TO BE A GOOD OPINION. HAD THE PROCEDURE DONE ON (B)(6) REALLY SIMPLE PROCEDURE NO COMPLICATION. WAS IN A LITTLE PAIN BUT RETURNED TO WORK THE NEXT DAY. HOWEVER, ON TUESDAY (B)(6), I HAD A FEVER OF 103.4 AND WAS NOT FEELING GOOD. CALLED MY OBGYN WHO SAID TO GO TO THE ER. WHEN I ARRIVED, BLOOD PRESSURE WAS 162/124 TEMP 104.0 AND O2 LEVEL 89. DID EKG IT WAS FINE CHEST X-RAY WAS CLEAR THEN HAD CAT SCAN THERE WAS FLUID IN MY FALLOPIAN TUBS AND UTERUS. WAS TRANSPORTED TO THE HOSPITAL WHERE OBGYN WAS AT. THEY GAVE ME FOUR ROUNDS OF I.V ANTIBIOTIC BY THIS TIME I WAS LETHARGIC. INFECT WAS BEGINNING TO SHOW UP IN MY BLOOD STREAM. THE DOCTOR CAME IN AND SAID I HAD TO HAVE A EMERGENCY HYSTERECTOMY AND TUBES REMOVED OR I WILL DIE. SURGERY WAS THREE HOURS AND LEFT ME ONLY ONE OVARY. WAS STILL IN ICU FOR THREE DAYS FIGHTING THE INFECTION. CAME HOME SUNDAY (B)(6) AND TRYING TO RECOVER FROM EVERYTHING. STILL CONFUSED WHAT HAPPEN AND WHY. I HAVE TOLD ALL MY FRIENDS NOT TO SO THIS PROCEDURE. SO SAD I DIDN'T WANT TO HAVE ANY MORE KIDS BUT DON'T KNOW HOW TO FEEL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352700 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 40.000 YR Hospitalization| L| S