BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3212345

    MDR report key: 3212345 · Received July 8, 2013

    Report

    Report Number
    3212345
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 18, 2013
    Report Date
    June 25, 2013
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    TIP OF FIRST SIDE OF ESSURE BROKE/STUCK IN PT'S FALLOPIAN TUBES.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ESSURE COIL INSERTION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR