BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7742888 · Received August 1, 2018

    Report

    Report Number
    MW5078804
    Event Type
    Injury
    Date Received
    August 1, 2018
    Date of Event
    September 3, 2013
    Report Date
    July 30, 2018
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP TO THE ORIGINAL FDA ADVERSE REPORT DATED (B)(6) 2013. MY ESSURE COIL REMOVAL WAS UNSUCCESSFUL. I HAD TO HAVE A SECOND SURGERY THIS PAST MONTH ((B)(6) 2018); THIS SURGERY WAS A FULL HYSTERECTOMY. REF # 2951250-2017-01264.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580178 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION HHS BAYER HEALTHCARE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| O| R