BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRESPONDER TOURNIQUET

    MDR report key: 4838796 · Received June 11, 2015

    Report

    Report Number
    0009615387-2015-00001
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 10, 2015
    Report Date
    September 1, 2015
    Manufacturer
    PYNG MEDICAL CORPORATION
    Product Code
    GAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    INSUFFICIENT INFORMATION PROVIDED TO DETERMINE CAUSE OF COMPLAINT. HOWEVER THIS LOT OF PRODUCT IS BEING RECALLED FOR INSPECTION. SEE RECALL NOTICE FOR MFR REPORT NUMBER 9615387-2015-00004.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER COMPLAINANT, THE TOURNIQUET RIPPED APART PRIOR TO TORQUING AND A PARAMEDIC CREATED A TOURNIQUET WHICH WAS USED TO STOP BLEEDING. THE ONLY OTHER INFORMATION OBTAINED WAS THAT THE PATIENT WAS UNSTABLE AT THE TIME OF THE INCIDENT AND IS NOW DECEASED. NO FURTHER INFORMATION HAS BEEN OBTAINED FROM THE COMPLAINANT AT THE TIME OF THIS REPORT FILING. PYNG MEDICAL WAS MADE AWARE OF THIS EVENT ON (B)(4) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383102 MATRESPONDER TOURNIQUET MATRESPONDER GAX PYNG MEDICAL CORPORATION MATR SL115802

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention