BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GASTROSTOMY TUBE

    MDR report key: 1023525 · Received April 2, 2008

    Report

    Report Number
    1527460-2008-00636
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    January 15, 2008
    Report Date
    March 5, 2008
    Manufacturer
    ROSS PRODUCTS DIVISION
    Product Code
    KNT
    PMA / PMN Number
    K861323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    COMPLAINANT REPORTS TUBE WAS INSERTED IN 2008 AND IT FELL OUT ABOUT 9 DAYS LATER. SHE MENTIONED THAT THE BALLOON IS LEAKING WHERE IT JOINED THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GASTROSTOMY TUBE 78 KNT, GASTROINTESTINAL AND ACCESSORIES KNT ROSS PRODUCTS DIVISION 155 54381VM

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR