BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4102073 · Received September 19, 2014

    Report

    Report Number
    MW5038239
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    June 20, 2014
    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

    #MEDWATCHER #FOLLOWUP1 #FDAMW5038239 (B)(4). SINCE THIS REPORT I HAVE HAD SURGERY TO REMOVE MY TUBES. MY SYMPTOMS NEVER WENT AWAY. AFTER A ER VISIT I DISCOVERED THAT THE COILS MIGRATED INTO MY ABDOMEN. I NOW WITH BE HAVING A HYSTERECTOMY AND ABDOMINAL SURGERY TO REMOVE THE COILS. I LIVE WITH DAILY PAIN AND NOW HAVE DEVELOPED MASSIVE CYST.

    Description of Event or Problem · 1

    #MEDWATCHER #FOLLOWUP2 #FDAMW5038239 #(B)(4) FOLLOW UP FROM HYSTERECTOMY.... ESSURE COIL WAS FOUND PERFORATED IN MY UTERUS(HALF IN AND HALF OUT). FRAGMENTS IN MY BLADDER AND SURROUNDING MY UTERUS. I WAS DIAGNOSED WITH ENDOMETRIOSIS.

    Description of Event or Problem · 1

    #MEDWATCHER #(B)(4) I WAS A HEALTHY WOMAN NO MEDICAL ISSUES UNTIL I HAD THE ESSURE PLACED IN (B)(6) 2013. FOR THE FIRST FEW MONTHS NO ISSUES, THEN MY PERIOD CAME ON MONTH AND HAS NEVER FULLY LEFT. IT IS GETTING SUPER HEAVY AND PAINFUL. I GET A DAY OR TWO BREAK FROM THE BLEEDING BUT THE PAIN NEVER ENDS AND CONTINUES TO WORSEN. I HAVE NIGHT SWEATS, PAIN AND NUMBNESS IN MY LEGS, PELVIC PRESSURE, CLOTTING, AND LOTS OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581689 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 32.000 YR Hospitalization| S