BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILLS-OGLESBY GASTROSTOMY CATHETER

    MDR report key: 963381 · Received December 13, 2007

    Report

    Report Number
    1820334-2007-00489
    Event Type
    Malfunction
    Date Received
    December 13, 2007
    Date of Event
    November 13, 2007
    Report Date
    November 14, 2007
    Manufacturer
    COOK, INC.
    Product Code
    EZK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: NO PRODUCT WAS RETURNED TO ASSIST IN OUR INVESTIGATION, HOWEVER, PHOTOS WERE PROVIDED, WHICH SHOWED THE TUBING HAS KNOTTED. BASED ON THE INFO PROVIDED AND THE CONDITION OF THE DEVICE IN THE PHOTO IMAGES, IT IS FEASIBLE TO SAY THE KNOT FORMED DURING PLACEMENT, AS THE RESULT OF PT ANATOMY OR POSSIBLE PT INTERVENTION. IT SHOULD BE NOTED THIS IS A SOFT, PLIABLE TUBING DESIGNED FOR PT COMFORT, THAT CAN BE MANIPULATED.

    Description of Event or Problem · 1

    INFO WAS PROVIDED THAT THE PHYSICIAN EXPERIENCED GREAT DIFFICULTY IN REMOVING THE TUBE FROM THE PT, REQUIRING INCREASED AMOUNTS OF ANALGESIA TO THE PT. UPON REMOVAL, IT WAS NOTED THAT THE TUBE HAD TIED ITSELF INTO A KNOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILLS-OGLESBY GASTROSTOMY CATHETER EZK- SPECIAL SET EZK COOK, INC. NA F2094835

    Patients

    Seq Age Sex Outcome Treatment
    1 YR