BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 1211787 · Received October 10, 2008

    Report

    Report Number
    1211787
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 10, 2008
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS TRYING TO LOAD THE ESSURE FOR TUBAL WHEN THE SPRING WOULD NOT UNLOAD. ITEM WAS REPLACED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE BIRTH CONTROL SYSTEM HHS CONCEPTUS, INC. ESS205 624001

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR