BEUDAMED
    FDA Adverse Event Other Summary report: N

    KODAK

    MDR report key: 1069170 · Received June 20, 2008

    Report

    Report Number
    MW5007507
    Event Type
    Other
    Date Received
    June 20, 2008
    Date of Event
    October 23, 2007
    Report Date
    June 20, 2008
    Manufacturer
    KODAK
    Product Code
    IXW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT SCHEDULED TO HAVE TWO UPPER LEFT AND RIGHT, AND THE LOWER RIGHT WISDOM TEETH EXTRACTED UNDER MODERATE SEDATION. THE FILM BASED RADIOGRAPH WAS ORIENTED INCORRECTLY ON THE VIEW WHICH RESULTED IN THE SURGICAL EXPLORATION OF THE WRONG AREA. UF-UNCONTROLLABLE FACTORS FILM-BASED PANORAMIC FILM MUST BE INVERTED ON THE VIEW BOX TO BE ORIENTED CORRECTLY. THE PANORAMIC FILM IS MARKED WITH AN "L" OR "R" IN THE APPROPRIATE CORNER, WHEN THE FILM IS PROPERLY PLACED ON THE VIEW BOX, THE "L" AND "R" ARE BACKWARDS. THIS HAS BEEN ACCEPTED AS AN INDUSTRY NORM BY THE PROFESSIONAL DENTAL COMMUNITY AND HAS BEEN ADDRESSED THROUGH CONTINUAL TRAINING AND ENSURING COMPLIANCE WITH UNIVERSAL PROTOCOL REQUIREMENTS. COULD THE WORDS -FRONT- BE PLACED ON THE FILM OR THE "L" AND "R" BE UNIVERSALLY CHANGED, SO THAT IT IS LOGICAL TO THE USER? DIAGNOSIS OR REASON FOR USE: X-RAYS FOR WISDOM TEETH EXTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KODAK E SPEED PANORAMIC FILM IXW KODAK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other