BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAT MECHANICAL ADVANTAGE TOURNIQUET

    MDR report key: 1931854 · Received November 30, 2010

    Report

    Report Number
    9615387-2010-00018
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 30, 2010
    Manufacturer
    PYNG MEDICAL CORP.
    Product Code
    GAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO PYNG MEDICAL CORP FOR FORMAL EVALUATION; HOWEVER, THE COMPLAINANT MENTIONED THAT THE DEVICE WAS USED ON 3 DIFFERENT SUBJECTS. THE MAT DEVICE IS A SINGLE USE DEVICE. WHILE NO FORMAL CONCLUSIONS CAN BE DRAWN AT THIS TIME, THE DEVICE WAS NOT BEING USED ACCORDING TO THE INTENDED USE (LABELING).

    Description of Event or Problem · 1

    DURING A TRAINING SESSION OF THE SKI PATROL AT SQUAW VALLEY SKI AREA, THE TRAINER APPLIED THE MAT TOURNIQUET TO THREE PEOPLE. ON THE THIRD TEST SUBJECT, DURING THE TIGHTENING OF THE TOURNIQUET, AS REPORTED BY THE COMPLAINANT, "THE MAT COMPLETELY FAILED" (WHICH WOULD PREVENT THE DEVICE FROM OPERATING AS INTENDED). NOTE: THE MAT DEVICE IS A SINGLE USE DEVICE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAT MECHANICAL ADVANTAGE TOURNIQUET GAX PYNG MEDICAL CORP. MAT01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other