BEUDAMED
    FDA Adverse Event Other Summary report: N

    KODAK DIRECTVIEW CR CASSETTE

    MDR report key: 736524 · Received July 1, 2006

    Report

    Report Number
    1317307-2006-00008
    Event Type
    Other
    Date Received
    July 1, 2006
    Date of Event
    April 5, 2006
    Report Date
    June 29, 2006
    Manufacturer
    EASTMAN KODAK COMPANY
    Product Code
    IXA
    PMA / PMN Number
    K925997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASSETTE HAS BEEN REMOVED FROM USE AND WILL BE EVALUATED BY KODAK ONCE RECEIVED.

    Description of Event or Problem · 1

    A CHEST X-RAY SHOWED AN OSTEOBLASTIC MALIGNANT TUMOR ON AN ELDERLY PT. ADDITIONAL RADIOGRAPHS OF THE SHOULDER AND HUMERUS DID NOT SHOW THE TUMOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other