BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DGW.035 FC R1.5MM 180CM PTFE

    MDR report key: 314820 · Received February 1, 2001

    Report

    Report Number
    1016427-2001-00023
    Event Type
    Malfunction
    Date Received
    February 1, 2001
    Date of Event
    January 3, 2001
    Report Date
    February 1, 2001
    Manufacturer
    CORDIS CORPORATION (MIAMI)
    Product Code
    MKI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COATING SEPARATED FROM THE WIRE AT THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4023 DGW.035 FC R1.5MM 180CM PTFE ENDOVASCULAR WIRES & METALS MKI CORDIS CORPORATION (MIAMI) NA F0500865

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death