BEUDAMED
    FDA Adverse Event Other Summary report: N

    KODAK DIRECTVIEW CR CASSETTE

    MDR report key: 576710 · Received February 28, 2005

    Report

    Report Number
    1317307-2005-00001
    Event Type
    Other
    Date Received
    February 28, 2005
    Date of Event
    January 4, 2005
    Report Date
    February 25, 2005
    Manufacturer
    EASTMAN KODAK COMPANY
    Product Code
    MQB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A COMPUTED RADIOGRAPHY (CR) SCREEN ARTIFACT RESEMBLING A 3/16" CIRCULAR WHITE DOT WAS NOTED ON 3 CLINICAL IMAGES USING THE KODAK DIRECTVIEW CR CASSETTE /35 X 43 CM WITH ATTACHED STORAGE PHOSPHOR (SP) SCREEN. THE WHITE DOT ARTIFACT WAS IDENTIFIED BY THE RADIOLOGIST AS AN IMAGE ARTIFACT AS IT WAS VISIBLE IN THE SAME LOCATION ON EACH OF THE 3 CLINICIAL IMAGES. AN INVESTIGATION WAS INITIATED ON THIS CUSTOMER COMPLAINT BECAUSE THE RADIOLOGIST HAD CONCERN THAT THIS WHITE DOT ARTIFACT COULD HAVE BEEN MISTAKEN FOR A LUNG NODULE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KODAK DIRECTVIEW CR CASSETTE CR CASSETTE WITH ATTACHED SP SCREEN MQB EASTMAN KODAK COMPANY NA 1706

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other