BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAT TOURNIQUET

    MDR report key: 2030887 · Received March 22, 2011

    Report

    Report Number
    MW5019938
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 22, 2011
    Manufacturer
    PYNG MEDICAL
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING CRUSH INJURY CALL, WE HAD TWO EQUIPMENT FAILURES FOR MAT TOURNIQUETS. FIRST DEVICE WAS PLACED AROUND LEFT PROXIMAL FEMUR. DURING THE PROCESS OF TIGHTENING THE TOURNIQUET WITH THE KEY, THE DEVICE BEGAN TO SLIP FREELY AS IF IT WAS STRIPPED ON THE RACHET. WE ATTEMPTED TO RELEASE THE DEVICE TO TURN THE KEY AGAIN, BUT THE RELEASE TAB WAS STUCK AND WOULD NOT ACTUATE. STRAP WAS CUT DUE TO INADEQUATE PRESSURE TO SITE AND EQUIPMENT MALFUNCTION WITH THE ABILITY TO RELEASE REMAINING TENSION. A SECOND MAT TOURNIQUET DEVICE WAS APPLIED TO THE SAME SITE. WHILE IN THE PROCESS OF TURNING KEY TO TENSION STRAP, THE PROXIMAL END OF THE STRAP WHICH WAS ATTACHED TO THE UNIT SEPARATED COMPLETELY AND WAS INOPERABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAT TOURNIQUET NA KCY PYNG MEDICAL NA 038

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability