BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS DISPENSER 1 0ML

    MDR report key: 824504 · Received November 2, 2006

    Report

    Report Number
    1056600-2006-00232
    Event Type
    Malfunction
    Date Received
    November 2, 2006
    Date of Event
    October 12, 2005
    Report Date
    November 2, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    GJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT DID NOT GENERATE ENOUGH INFORMATION TO DETERMINE A ROOT CAUSE. NO ANALYSIS WAS POSSIBLE, AND ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MTS DISPENSER DID NOT ASIPRATE OR DISPENSE CORRECTLY. IF THERE IS AN INCORRECT OR NO DISPENSE EVENT THAT GOES UNDETECTED, ERRONEOUS RESULTS COULD BE REPORTED. THERE WAS NO REPORT OF HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS DISPENSER 1 0ML DISPENSER GJG MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1