BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT LABORATORIES, INC.

    MDR report key: 582165 · Received February 25, 2005

    Report

    Report Number
    582165
    Event Type
    Malfunction
    Date Received
    February 25, 2005
    Date of Event
    January 24, 2005
    Report Date
    January 25, 2005
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MANIPULATION OF WIRE BELOW RIGHT KNEE IN TOTALLY OCCLUDED VESSEL RESULTED IN BREAKAGE OF WIRE TIP AND PIECE OF WIRE LEFT IN PT'S RIGHT LOWER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT LABORATORIES, INC. PTCA GUIDE WIRE DQX ABBOTT LABORATORIES, INC. GRAND SLAM 47056-13821

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other