BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DF 57C DENTAL X-RAY FILM

    MDR report key: 558326 · Received September 22, 2004

    Report

    Report Number
    MW1033299
    Event Type
    Malfunction
    Date Received
    September 22, 2004
    Date of Event
    September 21, 2004
    Report Date
    September 22, 2004
    Manufacturer
    EASTMAN KODAK
    Product Code
    IWZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    KODAK DF57C DENTAL INTRAORAL X-RAY FILM HAS SOME FILMS ENCLOSED IN A DEFECTIVE LIGHT PROOF COVER. THEY HAVE A SMALL SLIT IN THE SIDE OF THE COVER WHICH ALLOWS LIGHT ENTRANCE, RESULTING IN BLACKING OUT OF PART OF THE IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DF 57C DENTAL X-RAY FILM DENTAL X-RAY FILM IWZ EASTMAN KODAK DF 57C DENTAL X-RAY *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other