BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 4083788 · Received August 1, 2014

    Report

    Report Number
    4083788
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    May 5, 2014
    Report Date
    August 1, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    KNH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MD INSERTING ESSURE STERILIZATION COIL VIA HYSTEROSCOPY WHEN COIL DID NOT FULLY RELEASE INTO RIGHT FALLOPIAN TUBE. ONLY PART OF COIL WAS INSERTED. LEFT FALLOPIAN TUBE WENT WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449969 ESSURE DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE KNH BAYER HEALTHCARE LLC * B71765

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR