BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET

    MDR report key: 1413342 · Received June 26, 2009

    Report

    Report Number
    1820334-2009-00356
    Event Type
    Malfunction
    Date Received
    June 26, 2009
    Date of Event
    January 26, 2009
    Report Date
    May 29, 2009
    Manufacturer
    COOK, INC.
    Product Code
    EZK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE UNK AS LOT IS UNK. EVALUATION: STILL UNDER INVESTIGATION AT THIS TIME.

    Description of Event or Problem · 1

    COOK GASTROSTOMY FEEDING TUBE WAS PLACED IN 2009, PULLED AWAY FROM THE PLASTIC HUB AND THE THREAD BROKE IN THE SAME MONTH. IT COULD NOT BE REATTACHED, AND THE TUBE HAD TO BE REPLACED. WE WERE LATER ADVISED THAT THIS WAS AN ACCIDENTAL EVENT AS THEY CUT THE THREAD BECAUSE THEY DID NOT KNOW WHAT IT WAS. THE PT WAS TAKEN TO REHAB AND THEN RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET EZK CATHETER, RETENTION TYPE EZK COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR