BEUDAMED
    FDA Adverse Event Summary report: N

    O-Z COIL SPECIAL (OZ C CA2)

    MDR report key: 670235 · Received September 9, 2005

    Report

    Report Number
    1317749-2005-00041
    Date Received
    September 9, 2005
    Date of Event
    September 8, 2005
    Report Date
    September 8, 2005
    Manufacturer
    TYCO/KENDALL HEALTHCARE
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER HAD A PROBLEM WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS THERE IS LEAKAGE BETWEEN THE CUFF AND THE CUTTING AREA OF THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O-Z COIL SPECIAL (OZ C CA2) DIALYSIS CATHETER FJS TYCO/KENDALL HEALTHCARE 8888425710 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN