BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 1934744 · Received November 29, 2010

    Report

    Report Number
    1721504-2010-00397
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 4, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K934123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE COMPLAINT DATA BASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. A F/U REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. EVALUATION METHOD: THE DEVICE HISTORY RECORD WAS REVIEWED, THE COMPLAINT DATA BASE WAS REVIEWED. CONCLUSIONS: A F/U REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE ROTATOR BROKE DURING USE. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DTL MERIT MEDICAL SYSTEMS, INC. F726310

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST MEDIA