BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1944080 · Received December 20, 2010

    Report

    Report Number
    1944080
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 12, 2010
    Report Date
    December 20, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WIRE WOULD NOT PASS THROUGH SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * INTRODUCER, CATHETER DYB CORDIS CORPORATION * 15113369

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR