BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 2082106 · Received April 21, 2011

    Report

    Report Number
    2082106
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CONCEPTUS INC
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    ESSURE DEVICE WOULD NOT THREAD. IT SEEMED LIKE THE PLASTIC TIP WAS LOOSE AND COMING OFF. CAME OUT OF THE PACKAGE WITH THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE ESSURE PREMANENT BIRTH CONTROL SYSTEM HHS CONCEPTUS INC * 789036

    Patients

    Seq Age Sex Outcome Treatment
    1 *