BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 1934813 · Received December 3, 2010

    Report

    Report Number
    1934813
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 24, 2010
    Report Date
    December 3, 2010
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A STERILIZATION PROCEDURE WITH THE ESSURE DEVICE, THE COIL MALFUNCTIONED IN THE LEFT FALLOPIAN TUBE. THIS CAUSED THE HYSTEROSCOPY TO CHANGE TO AN OPEN PROCEDURE, AS THE DEFECTIVE COIL HAD TO BE REMOVED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================COIL MALFUNCTIONED.====================== MANUFACTURER RESPONSE FOR UTERO MICRO COIL FOR PERMANENT BIRTH CONTROL, ESSURE======================THE MANUFACTURER BELIEVED THE DEVICE MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 ESSURE UTERO MICRO COIL FOR PERMANENT BIRTH CONTROL HHS CONCEPTUS, INC. ESS305 50512931

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR