BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT TUBE

    MDR report key: 1232693 · Received November 14, 2008

    Report

    Report Number
    1527460-2008-00898
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    September 1, 2008
    Report Date
    October 16, 2008
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    KNT
    PMA / PMN Number
    K861323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REPORTED IS AN ABBOTT PRODUCT THAT IS MARKETED INTERNATIONALLY WHICH IS THE SAME OR SIMILAR TO A DEVICE THAT IS MARKETED DOMESTICALLY.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE PATIENT HAD A GASTROSTOMY TUBE PLACED AND THREE DAYS LATER, THE BALLOON RUPTURED AND THE TUBE FELL OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT TUBE KNT TUBES, GASTROINTESTINAL AND ACCESSORIES KNT ABBOTT NUTRITION 153 53327VM

    Patients

    Seq Age Sex Outcome Treatment
    1