BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2 EAS SYSTEM

    MDR report key: 3946374 · Received July 10, 2014

    Report

    Report Number
    3009124963-2014-00022
    Event Type
    Injury
    Date Received
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    KNT
    PMA / PMN Number
    K113351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REPEATED ATTEMPTS AT GATHERING INFORMATION, OBTAINING A TRACING OF THE PLACEMENT, AND RETURN OF THE CORTRAK SYSTEM FOR EVALUATION, THERE HAS BEEN NO RESPONSE FROM THE FACILITY. BECAUSE OF THIS, A DEFINITIVE CONCLUSION CANNOT BE MADE. CORPAK MEDSYSTEMS WILL CONTINUE TO WORK WITH THE FACILITY TO RECEIVE ADDITIONAL INFORMATION AS WELL AS THE RETURN OF CORTRAK SYSTEM FOR EVALUATION.

    Description of Event or Problem · 1

    A CORTRAK ASSISTED NASOGASTRIC TUBE INSERTION LED TO A LONG PLACEMENT. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME DESPITE NUMEROUS ATTEMPTS TO RECEIVE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403858 CORTRAK 2 EAS SYSTEM KNT CORPAK MEDSYSTEMS 20-0950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other