BEUDAMED
    FDA Adverse Event Other Summary report: N

    KODAK DIRECTVIEW CR CASSETTE

    MDR report key: 693729 · Received March 27, 2006

    Report

    Report Number
    1317307-2006-00004
    Event Type
    Other
    Date Received
    March 27, 2006
    Date of Event
    December 1, 2005
    Report Date
    March 23, 2006
    Manufacturer
    EASTMAN KODAK COMPANY
    Product Code
    MQB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THEIR CASSETTE HAD AN ARTIFACT. A PATIENT WAS IMAGED USING THIS CASSETTE AND THE ARTIFACT APPEARED AS A STEINSTRASSE COLLECTION OF KIDNEY STONES BASED ON ITS LOCATION IN THE PATIENT IMAGE. THE PATIENT WAS TAKEN TO THE OR WHERE A URETHRASCOPY WAS PERFORMED. NO KIDNEY STONES WERE FOUND. KODAK WAS INFORMED OF THIS EVENT ON FEBRUARY 23, 2006. FROM EVALUATION OF THE RETURNED SCREEN AND CASSETTE, KODAK CONCLUDES THAT THE SCREEN WAS EXPOSED TO A DAMAGNG CHEMICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KODAK DIRECTVIEW CR CASSETTE CR RIGID CASSETTE MQB EASTMAN KODAK COMPANY NA 1792

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other