BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 1900583 · Received October 29, 2010

    Report

    Report Number
    1721504-2010-00359
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXJ
    PMA / PMN Number
    K883718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. EVALUATION: CONCLUSIONS: A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE DEVICE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT ROTATOR BROKE ON THE END OF THE HIGH PRESSURE TUBING TWO (2) TIMES. THE LAB STAFF WAS NOT SPRAYED. NO HARM OR INJURY REPORTED. THIS IS ONE OF TWO REPORTS: 1721504-2010-00360.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT DISPLAY, CATHODE-RAY-TUBE, MEDICAL DXJ MERIT MEDICAL SYSTEMS, INC. F677641

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA