BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 2042566 · Received March 28, 2011

    Report

    Report Number
    2042566
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    CONCEPTUS INCORPORATED
    Product Code
    KNH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US

    Narratives

    Description of Event or Problem · 1

    DURING HYSTERSCOPIC FALLOPIAN TUBE OCCULUSION, FIRST ESSURE DEVICE WAS INSERTED AND FAILED TO DEPLOY CORRECTLY. SPRING DID NOT EXPAND AND REMAINED INSIDE PATIENT. SPRING WAS REMOVED FROM PATIENT BY MD AND SAVED ALONG WITH PRODUCT PACKAGING. DELIVERY DEVICE WAS DISCARDED BY OR STAFF.====================== MANUFACTURER RESPONSE FOR PERMANENT BIRTH CONTROL SYSTEM, ESSURE======================MANUFACTURER REP WAS CONTACTED BY OR CASE STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE PERMANENT BIRTH CONTROL SYSTEM KNH CONCEPTUS INCORPORATED * 12441794

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR