BEUDAMED
    FDA Adverse Event Summary report: N

    SLIP-CATH, BEACON, KMP

    MDR report key: 1051506 · Received April 28, 2008

    Report

    Report Number
    1051506
    Date Received
    April 28, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 28, 2008
    Manufacturer
    COOK UROLOGICAL INCORPORATED
    Product Code
    DQO
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PERCUTANEOUS UROSTOMY TUBE PLACEMENT ATTEMPT, THE CATHETER (KMP) THE TIP WAS NOTED TO BE SEPARATED FROM THE CATHETER BY VISUALIZATION ON FLUOROSCOPY AT THE STONE. IT APPEARS THAT THE TIP MAY HAVE BECOME ADHERENT TO A LARGE URINARY STONE CAUSING THE TIP TO SEPARATE FROM THE CATHETER. ATTEMPTS TO RECANNULATE AND ASPIRATE FRAGMENT FAILED. THE FRAGMENT MOVED DOWNSTREAM TO THE BLADDER AND IS EXPECT TO PASS VIA URINATION WITHOUT ANY INCONVENIENCE FOR THE PATIENT. THE PATIENT AND HIS FAMILY WERE MADE AWARE BY THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIP-CATH, BEACON, KMP CATHETER, PERIPHERAL DQO COOK UROLOGICAL INCORPORATED * 1918877

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR