BEUDAMED
    FDA Adverse Event Other Summary report: N

    KODAK DIRECTVIEW CR FLEXIBLE PHOSPHOR SCREEN

    MDR report key: 576668 · Received February 28, 2005

    Report

    Report Number
    1317307-2005-00003
    Event Type
    Other
    Date Received
    February 28, 2005
    Date of Event
    February 3, 2005
    Report Date
    February 25, 2005
    Manufacturer
    EASTMAN KODAK COMPANY
    Product Code
    MQB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A COMPUTED RADIOGRAPHY (CR) 500 SCREEN ARTIFACT WAS REPORTED BY THE CUSTOEMR SITE TO RESEMBLE A HYPERTROPHIC CALCIFICATION IN THE HIP AREA (TUMOR). THE RADIOLOGIST WAS ABLE TO DETERMINE THAT THIS WAS AN ARTIFACT AS IT APPEARED IN OTHER IMAGES IN THE SAME LOCATION. THERE WERE NO REPORTS OF PT INJURY. KODAK HAS REVIEWED THE CLINICAL AND FLAT FIELD IMAGES FROM THIS CUSTOMER SITE. THE TYPE OF ARTIFACT RESEMBLES AN IRREGLAR SHAPE. IT WAS ALSO REPORTED THAT AN IMAGE ARTIFACT RESEMBLED A "RARE TUMOR" ON A CHEST IMAGE, AND UPON REVIEW OF OTHER IMAGES THE RADIOLOGIST NOTED THE SAME ARTIFACT (RESEMBLING THE "RARE TUMOR") IN THE SAME LOCATIONS AS THE FIRST IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KODAK DIRECTVIEW CR FLEXIBLE PHOSPHOR SCREEN CR STORAGE PHOSPHOR SCREEN MQB EASTMAN KODAK COMPANY NA 1805

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other