BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE CATHETER SYSTEM

    MDR report key: 6108978 · Received November 17, 2016

    Report

    Report Number
    6108978
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    July 5, 2016
    Report Date
    October 28, 2016
    Manufacturer
    COVIDIEN, LLC
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON OPENING DEVICE NOTED TIP OF EWC WAS KINKED. DEVICE NOT USED DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759174 EDGE CATHETER SYSTEM SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK COVIDIEN, LLC EK05723

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR