BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 3792080 · Received April 22, 2014

    Report

    Report Number
    3792080
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    September 3, 2013
    Report Date
    November 20, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    WHEN PREPARING FOR INSERTION, THE ESSURE MISFIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243733 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER HEALTHCARE LLC ESS305 50713475

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR