BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAGNOSTIC GUIDEWIRE .035 FC J3MM 150CM TEF

    MDR report key: 614499 · Received July 23, 2004

    Report

    Report Number
    1016427-2004-00077
    Event Type
    Malfunction
    Date Received
    July 23, 2004
    Date of Event
    July 9, 2004
    Report Date
    July 23, 2004
    Manufacturer
    CORDIS CORPORATION (MIAMI)
    Product Code
    MKI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GUIDEWIRE FRACTURED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAGNOSTIC GUIDEWIRE .035 FC J3MM 150CM TEF CARDIOLOGY WIRES & METALS MKI CORDIS CORPORATION (MIAMI) NA F0404747

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR