BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT TUBE

    MDR report key: 1860166 · Received September 21, 2010

    Report

    Report Number
    1527460-2010-00172
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 24, 2010
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    KNT
    PMA / PMN Number
    K861323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFG EVENT ID: (B)(4) . ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFORMATION FROM THE SOURCE.

    Description of Event or Problem · 1

    SAME CASE AS #1527460-2010-00171. THE COMPLAINANT REPORTED A BALLOON BURST. IT IS UNK HOW LONG THE REPLACEMENT TUBE WAS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT TUBE KNT, TUBES GASTROINTESTINAL AND ACCESSORIES KNT ABBOTT NUTRITION 51364

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR