BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LFX GENERATOR

    MDR report key: 127200 · Received October 17, 1997

    Report

    Report Number
    2122726-1997-00035
    Event Type
    Injury
    Date Received
    October 17, 1997
    Date of Event
    August 14, 1997
    Report Date
    October 17, 1997
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    IZO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE THAT THE PATIENT SHOWED SIGNS OF A RADIATION BURN BELOW THE RIGHT SHOULDER AREA OF 19CM BY 12CM. THE PROCEDURE WAS AN 11-HOUR EXAM WITH 3 HR. + OF FLOURO WITH 300 R OF DOSE. THE BURN WAS FROM THE LATERAL TUBE OF THE BIPLANE POSTIONER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LFX GENERATOR DIAGNOSTIC X-RAY IZO GE MEDICAL SYSTEMS 46-275911G8 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other