BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILMET

    MDR report key: 399292 · Received June 10, 2002

    Report

    Report Number
    MW1025281
    Event Type
    Malfunction
    Date Received
    June 10, 2002
    Manufacturer
    SILMET USA
    Product Code
    IWZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO RPTR SILMET USA SELLS A DANGEROUS PRODUCT. THE PRODUCT IS THEIR $17.95 BOX OF DENTAL X-RAY FILM FROM CHINA. THIS DENTAL X-RAY FILM HAS THE DIRECTIONAL INDICATOR DOT BACKWARDS FROM ALL OTHER FILM. RPTR HAS SEEN IN THE UNITED STATES SUCH AS THE INDUSTRY STANDARD BY KODAK, FLOW, AND AGFA. THE RESULT OF THIS FILM USE IS BACKWARD FILM PRESENTATIONS. THIS PROBLEM COULD BE MISSED BY THE USER CAUSING THE WRONG PT TOOTH TO BE TREATED. THIS PROBLEM COULD BE MISSED BY ANOTHER DR WHEN FILMS ARE ROUTINELY TRANSMITTED BETWEEN DRS RESULTING IN THE WRONG TOOTH TREATED. RPTR HAS COMPLAINED TO THE CO AS TO THE DANGER OF THIS FILM. TO THEIR KNOWLEDGE THEY ARE STILL SELLING THIS FILM WITH NO CORRECTIONS OR WARNINGS TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILMET DENTAL X-RAY FILM IWZ SILMET USA NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA