BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT TUBE

    MDR report key: 1063034 · Received June 19, 2008

    Report

    Report Number
    1527460-2008-00835
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 20, 2008
    Product Code
    KNT
    PMA / PMN Number
    K861323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, THERE IS NO SAMPLE TO RETURN. ROSS STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.

    Description of Event or Problem · 1

    COMPLAINANT REPORTS A LEAK FROM BOTH PORTS IMMEDIATELY AFTER PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT TUBE KNT, TUBES, GASTROINTESTINAL AND ACCESSORIES KNT 51366

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR