BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-MAT

    MDR report key: 4878805 · Received June 30, 2015

    Report

    Report Number
    0009615387-2015-00002
    Event Type
    Malfunction
    Date Received
    June 30, 2015
    Date of Event
    November 25, 2014
    Report Date
    June 30, 2015
    Manufacturer
    PYNG MEDICAL CORPORATION
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE E-MAT DEVICE USED IN THE FIELD WAS NOT AVAILABLE FOR RETURN, HOWEVER, THE COMPLAINANT RETURNED A USED DEVICE WHICH, PER THE COMPLAINANT, WAS BROKEN DURING A TRAINING SESSION. THE E-MAT WAS FROM THE SAME LOT AS THE E-MAT USED IN THE FIELD. ANOTHER E-MAT FROM THE SAME LOT, STILL IN THE ORIGINAL PACKAGING, WAS ALSO RETURNED. EVALUATION OF THE BROKEN RETURNED DEVICE SHOWED THAT THE BROKEN CORD WAS FULLY WOUND AROUND THE TURNKEY MECHANISM, INDICATING THAT IT HAD BEEN OVER-TIGHTENED BEYOND ITS TRAVEL LIMIT AS A RESULT OF USER ERROR. MULTIPLE LOT TENSILE TESTING OF THE CORD MET MANUFACTURER SPECIFICATIONS. (B)(4). PYNG MEDICAL IS FILING THIS REPORT AS A CONSERVATIVE INTERPRETATION OF THE FDA REGULATIONS, IN AN ABUNDANCE OF CAUTION, AND AS A MORE STRICT INTERPRETATION OF INTERNAL SOPS REGARDING THE FILING OF EVENTS OCCURRING OUTSIDE OF THE US.

    Description of Event or Problem · 1

    PATIENT SUFFERED LEG AMPUTATION FROM A SHREDDING MACHINE. E-MAT TOURNIQUET WAS APPLIED TO THIGH AND BROKE APART AFTER TIGHTENING. THE INTERNAL STRING TO THE WINDING MECHANISM BROKE. A SECOND TOURNIQUET FROM ANOTHER MANUFACTURER WAS USED SUCCESSFULLY TO STOP THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421692 E-MAT E-MAT EMERGENCY TOURNIQUET FMI PYNG MEDICAL CORPORATION E-MAT 1128

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention