BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK INC.

    MDR report key: 201534 · Received December 4, 1998

    Report

    Report Number
    201534
    Event Type
    Malfunction
    Date Received
    December 4, 1998
    Date of Event
    October 28, 1998
    Report Date
    November 10, 1998
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    4 FR PIGTAIL CATHETER WAS KINKED AND UNABLE TO BE REMOVED BY THE USUAL MEANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK INC. PIGTAIL CATHETER DQO COOK, INC. HN4.0-35-100-P-105-PIG 813229

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR