BEUDAMED
    FDA Adverse Event Summary report: N

    KENDRICK'S OTHER DEVICE FOR EXTRICATION

    MDR report key: 2606792 · Received August 13, 2008

    Report

    Report Number
    3002754225-2008-00001
    Date Received
    August 13, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 2, 2008
    Manufacturer
    EMERGENCY PRODUCTS & RESEARCH
    Product Code
    IQF
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST TIME THIS PRODUCT HAS HAD A REPORTED MALFUNCTION. EMERGENCY PRODUCTS & RESEARCH HAS PRODUCED THOUSANDS OF THESE PRODUCTS. IT IS AN INDUSTRY STANDARD. AFTER TALKING WITH THE REPORTER, HE STATED THAT IN 20 YEARS, THIS IS THE FIRST TIME HE HAS ENCOUNTERED A PROBLEM WITH THIS DEVICE. IT IS AN ISOLATED INCIDENT. THE REPORTER SENT THE DEVICE BACK TO THE DISTRIBUTOR. AFTER REPEATED REQUESTS, WE HAVE YET TO HAVE IT RETURNED TO US FOR EVALUATION.

    Description of Event or Problem · 1

    OUR EXTRICATION DEVICE WAS USED TO IMMOBILIZE A PT. ONE OF THE WOODEN SUPPORT SLATS BROKE (EITHER BEFORE APPLICATION OR DURING, IT IS UNK). AS THERE ARE SEVERAL SUPPORT SLATS, IT DID NOT RESULT IN AN ADVERSE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDRICK'S OTHER DEVICE FOR EXTRICATION KODE 1 RESCUE VEST IQF EMERGENCY PRODUCTS & RESEARCH

    Patients

    Seq Age Sex Outcome Treatment
    1