BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH INFLATION SYRINGE KIT

    MDR report key: 1900210 · Received October 23, 2010

    Report

    Report Number
    1721504-2010-00336
    Event Type
    Malfunction
    Date Received
    October 23, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    MAV
    PMA / PMN Number
    K011811
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE DEVICE EVAL HAS NOT BEEN COMPLETED. EVAL: CONCLUSIONS: OTHER: A F/U REPORT WILL BE SUBMITTED WHEN THE DEVICE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR OF THE INFLATION DEVICE BROKE WHEN BEING ATTACHED. NO HARM OR INJURY REPORTED. THE CUSTOMER REPORTED TWO (2) DEFECTIVE DEVICES BUT HAS NOT PROVIDED ANY ADD'L INFO OR CLINICAL DETAILS FOR THE ADD'L EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARCH INFLATION SYRINGE KIT SYRINGE, BALLOON INFLATION MAV MERIT MEDICAL SYSTEMS, INC. H154753

    Patients

    Seq Age Sex Outcome Treatment
    1