BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD TKO ANTI REFLUX DEVICE

    MDR report key: 1980059 · Received January 31, 2011

    Report

    Report Number
    MW5019247
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    November 20, 2010
    Report Date
    January 31, 2011
    Manufacturer
    HOSPIRA INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TKO DEVICE UNABLE TO BE REMOVED FROM CENTRAL LINE BY 2 RN'S. THIRD RN FINALLY ABLE TO REMOVE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD TKO ANTI REFLUX DEVICE NONE FPA HOSPIRA INC

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR