BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KODAK ULTRA-SPEED

    MDR report key: 746931 · Received November 9, 2005

    Report

    Report Number
    MW1037136
    Event Type
    Malfunction
    Date Received
    November 9, 2005
    Date of Event
    October 24, 2005
    Report Date
    October 31, 2005
    Manufacturer
    *
    Product Code
    IWZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENATL X-RAY FILM IS DEFECTIVE. KODAK ULTRASPEED DF-58 SIZE 2, MADE IN FRANCE. THE IMAGE DEVELOPS A MOTH EATEN APPEARANCE SHORTLY AFTER DEVELOPED. BEFORE RPTR KNEW IT WAS THE FILM RPTR WAS CHANGING THE SOLUTIONS, REINSTRUCTING THE ASSISTANTS. BECAUSE OF THE PROBLEM, RPTR HAD TO RETAKE SEVERAL X-RAYS. RPTR IS UPSET KODAK DID NOT SEND A RECALL NOTICE TO SUPPLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KODAK ULTRA-SPEED DENTAL X-RAY FILM IWZ * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *