BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5154248 · Received October 15, 2015

    Report

    Report Number
    MW5057035
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    February 2, 2013
    Report Date
    October 14, 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). SUDDEN STABBING PAIN ESPECIALLY WHEN STANDING FROM SITTING. TERRIBLE CRAMPS AND NEVER ENDING SPOTTING. MY OBGYN (B)(6) WITH THE U OF U CONFIRMED THAT MY COILS HAD MIGRATED TO MY UTERUS. I HAD TO HAVE SURGERY TO REMOVE THEM. HE WAS ONLY ABLE TO REMOVE A PORTION OF THE LEFT COIL AND IT HAS NOW STARTED HAVING ISSUES AND I CAN'T FIND A DOCTOR WHO CAN HELP ME BECAUSE MY INSURANCE CHANGED AND DR (B)(6) IS NOT COVERED. THERE IS NO EDUCATION BEING GIVEN TO DOCTORS AT ALL ABOUT SAFE WAYS TO REMOVE THE COILS OR ALTERNATIVES TO A FULL HYSTERECTOMY WHEN A PERSON IS YOUNG OR WANTS TO TRY IVF. IT'S CONSTANT PAIN AND NO ONE GETS IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681862 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 32.000 YR Hospitalization| O| R