BEUDAMED
    FDA Adverse Event Summary report: N

    FUJIFILM IMAGING PLATE

    MDR report key: 4176288 · Received September 26, 2014

    Report

    Report Number
    4176288
    Date Received
    September 26, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 26, 2014
    Manufacturer
    FUJIFILM MEDICAL SYSTEM U.S.A., INC.
    Product Code
    IXA
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    A FOREIGN BODY (WIRE) WAS IDENTIFIED ON PATIENT'S FOREARM X-RAY. FILM REVIEWED AND CONFIRMED BY A RADIOLOGIST. APPROXIMATELY 2 WEEKS LATER, PATIENT WAS IN SURGERY AND SEDATED FOR SURGICAL INTERVENTION TO REMOVE THE WIRE. THE SURGEON WAS UNABLE TO LOCATE THE FOREIGN BODY UNDER FLUORO IN THE OR. THE RAD TECH WHO WAS OPERATING THE FLUORO LOOKED AT THE IMAGES FROM THE PREVIOUS EXAM. TECH MANIPULATED THOSE IMAGES AND DISCOVERED THAT THE FOREIGN BODY THAT WAS IDENTIFIED WAS NOT A FOREIGN BODY. IT WAS A DEFECT ON THE X-RAY IMAGING PLATE. SURGERY WAS THEN ENDED. IMAGING PLATE WAS TAKEN OUT OF SERVICE. DEFECT ON IMAGING PLATE DID NOT APPEAR ON PREVIOUS FILMS. NO OTHER PATIENTS AFFECTED. DEFECT ON THE IMAGING PLATE WAS NOT VISIBLE DURING/PRIOR TO THIS PATIENT'S RADIOLOGICAL EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600482 FUJIFILM IMAGING PLATE CASSETTE, RADIOGRAPHIC FILM IXA FUJIFILM MEDICAL SYSTEM U.S.A., INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR