BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 FR GASTROSTOMY TUBE

    MDR report key: 1031359 · Received April 18, 2008

    Report

    Report Number
    1527460-2008-00671
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 20, 2008
    Manufacturer
    ROSS PRODUCTS DIVISION
    Product Code
    KNT
    PMA / PMN Number
    K861323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT GASTROSTOMY TUBES WERE POPPING AND SLIDING OUT OF THE SITE. THE BALLOONS WERE FILLED WITH 8CC - 15CC'S OF FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 20 FR GASTROSTOMY TUBE KNT TUBES, GASTROINTESTINAL AND ACCESSORIES KNT ROSS PRODUCTS DIVISION 51364 60600GZ

    Patients

    Seq Age Sex Outcome Treatment
    1