BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDRICK

    MDR report key: 1069174 · Received July 2, 2008

    Report

    Report Number
    MW5007511
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 2, 2008
    Manufacturer
    EMERGENCY PRODUCTS AND RESEARCH
    Product Code
    IQF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PROD WAS A KENDRICK OTHER DEVICE FOR EXTRICATION - K.O.D.E.-. THE PROD IS A SPINAL IMMOBILIZATION DEVICE. ONE OF THE WOODEN SLATS THAT MAKES UP THE DEVICE BROKE AFTER IT WAS APPLIED TO THE PT, AND WHILE REMOVING THE PT FROM THE VEHICLE. THE DEVICE IS MADE UP OF MULTIPLE WOODEN SLATS, THEREFORE, THERE WAS NO INJURY TO THE PT AS A RESULT OF THE FAILURE OF THE EQUIPMENT. THE EQUIPMENT WAS REMOVED FROM SVC IMMEDIATELY AFTER REMOVAL FROM THE PT. THE FAILURE OF THE EQUIPMENT WAS REPORTED TO THE VENDOR FROM WHOM THE EQUIPMENT WAS PURCHASED. DATES OF USE: FIRST USE 2008. REASON FOR USE: USED FOR VEHICLE EXTRACTION OF PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDRICK KENDRICK'S OTHER DEVICE FOR EXTRACTION - K.O.D.E. - IQF EMERGENCY PRODUCTS AND RESEARCH KE-823 1024

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR