BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK AIRWAY EXCHANGE CATHETER

    MDR report key: 5371010 · Received January 15, 2016

    Report

    Report Number
    1820334-2015-00885
    Event Type
    Injury
    Date Received
    January 15, 2016
    Date of Event
    December 10, 2015
    Report Date
    December 15, 2015
    Manufacturer
    COOK INC
    Product Code
    KTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: LRC, INSTRUMENT, ENT MANUAL SURGICAL. LOT NUMBER REQUESTED BUT NOT PROVIDED. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DURING AN ENDOTRACHEAL TUBE REPLACEMENT PROCEDURE DUE TO A POROUS BALLOON, THE REPORTER LISTS BILATERAL PNEUMOTHORAX AND CARDIAC ARREST AS CONSEQUENCES. ADDITIONAL INFORMATION RECEIVED ON 12JAN2016 DETERMINED THIS EVENT TO BE REPORTABLE: ACCORDING TO THE INITIAL REPORTER, THE PATIENT REQUIRED AN EXTERNAL CARDIAC MASSAGE AND BILATERAL DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28789 COOK AIRWAY EXCHANGE CATHETER KTI COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1