BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACER METRO DIRECT WIRE GUIDE

    MDR report key: 512511 · Received January 16, 2004

    Report

    Report Number
    1037905-2004-00009
    Event Type
    Malfunction
    Date Received
    January 16, 2004
    Report Date
    December 17, 2003
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    EZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PHYSICIAN USED A WILSON-COOK TRACER METRO DIRECT WIRE GUIDE. DURING USE, THE COATING OF THE WIRE GUIDE SEPARATED NEAR THE DISTAL END AND DETACHED FROM THE WIRE GUIDE. THE DETACHED PORTION WAS LEFT TO PASS NATURALLY THROUGH THE GASTROINTESTINAL TRACT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACER METRO DIRECT WIRE GUIDE COATED WIRE GUIDES EZM WILSON-COOK MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN