BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3781364 · Received April 30, 2014

    Report

    Report Number
    MW5035817
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 13, 2014
    Report Date
    April 18, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD MY ESSURE PLACED ON (B)(6) AND MY DOCTOR HAD TO PUT ONE SET IN AND REMOVE THEM AND THEN PLACE ANOTHER SET. THE FIRST SET BROKE OFF INSIDE WHICH SHE DID NOT KNOW AND WHEN SHE PLACED THE SECOND SET IT PIERCED THROUGH MY FALLOPIAN TUBE AND HIT A FAT POCKET ALMOST PERFORATING MY BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259380 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 26.000 YR Other