BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KODAK INSIGHT VHC CHEST FILM

    MDR report key: 35676 · Received July 8, 1996

    Report

    Report Number
    35676
    Event Type
    Malfunction
    Date Received
    July 8, 1996
    Date of Event
    December 30, 1995
    Report Date
    January 24, 1996
    Manufacturer
    KODAK HEALTH IMAGING SYSTEM, INC.
    Product Code
    IWZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED THROUGH THE EMERGENCY DEPT WITH CHEST PAIN. CXR REVEALED FREE AIR BELOW THE LEFT HEMIDIAPHRAGM, REPEAT CXR REVEALED THE SAME. DIAGNOSIS IN ED PERFORATED ABDOMINAL VISCOUS, PROBABLE PERFORATED ULCER. TAKEN TO SURGERY FOR EMERGENCY LAPAROTOMY, UPON EXPLORATION NO PERFORATION WAS LOCATED ANYWHERE WITHIN THE STOMACH OR GI TRACT. GANGRENOUS GALLBLADDER WAS FOUND AND REMOVED. UPON REVIEW BY THE RADIOLOGIST FELT FREE AIR NOTED ON FILM WAS ACTUALLY ARTIFACT ON THE FILM. CONCERN IS POTENTIAL EXISTED FOR UNNECCESSARY SURGERY. CO WAS CONTACTED ON TUESDAY 1/2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KODAK INSIGHT VHC CHEST FILM RADIOLOGICAL CXR FILM IWZ KODAK HEALTH IMAGING SYSTEM, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR