BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK ACUJECT INJECTOR NEEDLE

    MDR report key: 2032634 · Received March 23, 2011

    Report

    Report Number
    MW5019946
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 23, 2011
    Manufacturer
    COOK MEDICAL, INC.
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PENTAX VIDEOSCOPE OF COLON, A CARCINOMA OF THE COLON WAS IDENTIFIED. MD ATTEMPTED TO MARK TATTOO WITH (B)(6) INK USING ACUJECT INJECTOR NEEDLES. THREE FAILED. THE LAST SUCCEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK ACUJECT INJECTOR NEEDLE INJECTOR NEEDLE GAA COOK MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other