BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNA-PORT GASTROSTOMY TUBE

    MDR report key: 1032943 · Received April 23, 2008

    Report

    Report Number
    1527460-2008-00694
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 25, 2008
    Manufacturer
    ROSS PRODUCTS DIVISION
    Product Code
    KNT
    PMA / PMN Number
    K861323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROSS STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED PORTS LEAK. THE TUBE WAS LEAKING AROUND BOTH PORTS AND AROUND THE STOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNA-PORT GASTROSTOMY TUBE KNT TUBES, GASTROINTESTINAL AND ACCESSORIES KNT ROSS PRODUCTS DIVISION 54738

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR