BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 1221123 · Received October 23, 2008

    Report

    Report Number
    1221123
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    June 20, 2008
    Report Date
    October 23, 2008
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE SURGEON ATTEMPTED TO DEPLOY THE DEVICE ON THE RIGHT SIDE, IT DID NOT DEPLOY. THE SURGEON THEN ATTEMPTED TO DEPLOY THE DEVICE ON THE LEFT SIDE. THE DEVICE CAME OUT AFTER IT WAS INSERTED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 ESSURE BIRTH CONTROL SYSTEM HHS CONCEPTUS, INC. * 626625

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR