BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4113835 · Received September 24, 2014

    Report

    Report Number
    MW5038271
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    July 2, 2013
    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

    (B)(4). THE COIL WAS PUT INTO MY LEFT TUBE AND IT MIGRATED INTO MY UTERUS CAUSING IT TO PERFORATE MY UTERUS CAUSING INTERNAL BLEEDING. THE COIL STARTED MIGRATING AGAIN INTO MY OVARY AREA AND BOWELS AND BLADDER HAVE HAD TO HAVE TWO MAJOR SURGERIES DUE TO THE ESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595405 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 30.000 YR Other| S