BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KTI SPECIAL SET

    MDR report key: 927933 · Received October 9, 2007

    Report

    Report Number
    1820334-2007-00359
    Event Type
    Injury
    Date Received
    October 9, 2007
    Report Date
    August 13, 2007
    Manufacturer
    COOK INC.
    Product Code
    KTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: NO PRODUCT WAS RETURNED; HOWEVER, BASED ON THE INFO PROVIDED, IT IS FEASIBLE TO SAY THE DEVICE CAME IN CONTACT WITH A SHARP OR HARD OBJECT DURING ADVANCEMENT OR WITHDRAWAL. WE DO STATE IN OUR INSTRUCTIONS FOR USE BOOKLET; "ADVANCE THE INTRODUCER INTO THE TRACHEA. IF RESISTANCE IS ENCOUNTERED DO NOT FORCE THE INTRODUCER; GENTLY ROTATE AND ADVANCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KTI SPECIAL SET KTI COOK INC. NA 1807941

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention