BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT TUBE

    MDR report key: 2001536 · Received January 26, 2011

    Report

    Report Number
    1527460-2011-00006
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 4, 2011
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    KNT
    PMA / PMN Number
    K861323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.

    Description of Event or Problem · 1

    SAME CASE AS 1527460-2011-00005. THE COMPLAINANT REPORTED A BALLOON BURST. IT IS UNK WHEN THE TUBE WAS PLACED; HOWEVER, THE BALLOON BURST ON (B)(6), 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR