BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNA MED INC.

    MDR report key: 828659 · Received February 22, 2007

    Report

    Report Number
    MW1042206
    Event Type
    Malfunction
    Date Received
    February 22, 2007
    Report Date
    February 22, 2007
    Manufacturer
    DYNA MED INC.
    Product Code
    HST
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE RECEIVED AN ADVISORY FROM THE DEPARTMENT OF PUBLIC HEALTH OFFICE OF EMERGENCY MEDICAL SERVICES BACK ON 11/28/2006 REGARDING POSSIBLE FAILURES OF THE HEAT WELD ON THE ISCHIAL STRAP ON HARE TRACTION SPLINTS. TODAY, 02/22/2007, DURING ONE OF OUR INSPECTIONS OF OUR DYNA MED INC. HARE TRACTION SPLINT THE HEAT WELD FAILED ON THE ISCHIAL STRAP, SEPARATING COMPLETELY. THE SPLINT WAS IMMEDIATELY TAKEN OUT OF SERVICE AND WE ARE TRYING TO FIND OUT IF THERE IS A REPLACEMENT FOR THE STRAP OR IF WE WILL NEED TO REPLACE THE ENTIRE SPLINT. WE HAVEN'T HAD ANY LUCK TO FINDING A REPLACEMENT STRAP YET TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNA MED INC. HARE TRACTION SPLINT HST DYNA MED INC. M 1001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *