BEUDAMED
    FDA Adverse Event Summary report: N

    PERCUTANEOUS CATHETER SPECIAL INTRODUCER KIT

    MDR report key: 498186 · Received November 13, 2003

    Report

    Report Number
    MW1030193
    Date Received
    November 13, 2003
    Manufacturer
    SUN MEDICAL, INC.
    Product Code
    DYB
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGONING ENDOSCOPIC NERVE ROOT ADHESOLYSIS AT L5-S1 LEVEL FOR POST LAMINECTOMY SYNDROME. INTRODUCER SHEATH APPARENTLY TORE WHEN THE SCOPE WAS ADVANCED THRU IT. THE PROCEDURE WAS ABORTED, AND THE SCOPE WAS REMOVED, BUT A PIECE OF THE INTRODUCER WAS LEFT BEHIND. THE SMALL INCISION WAS CLOSED, AND THE PT WAS REFERRED TO ANOTHER HOSPITAL FOR FOLLOW-UP CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS CATHETER SPECIAL INTRODUCER KIT #9 FR RADIOPAQUE SHEATH DYB SUN MEDICAL, INC. 2160-901 60271863

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR