BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DGW GUIDEWIRE

    MDR report key: 482971 · Received September 8, 2003

    Report

    Report Number
    1016427-2003-00168
    Event Type
    Malfunction
    Date Received
    September 8, 2003
    Date of Event
    August 5, 2003
    Report Date
    September 8, 2003
    Manufacturer
    CORDIS CORP. (MIAMI)
    Product Code
    MKI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COATING SEPARATION FORM THE COREWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DGW GUIDEWIRE CARDIOLOGY WIRES & METALS MKI CORDIS CORP. (MIAMI) NA N0303105

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN