BEUDAMED
    FDA Adverse Event Summary report: N

    LINEAR ACCELERATOR

    MDR report key: 32485 · Received April 30, 1996

    Report

    Report Number
    32485
    Date Received
    April 30, 1996
    Date of Event
    April 10, 1996
    Report Date
    April 19, 1996
    Manufacturer
    UNKNOWN
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRESCRIPTION FOR THE PT WAS 300C GY 1 FX GIVEN DOSE FOR 15 FRACTIONS WITH 6 MCV ELECTRONS TO AN AREA OF HIS RIGHT EAR. THE TREATMENT FIELD WAS SET UP USING THE 5CM DIAMETER PLASTIC TIP CONE. ACCELERATOR MONITOR UNITS NEEDED TO DELIVER THE PRESCRIBED DOSE WERE CALCULATED USING OUTPUT FACTORS FOR THE 5CM DIAMETER METAL CONE. THIS RESULTED IN THE PT RECEIVING 7 TREATMENTS OF 414C GY GIVEN DOSE (2898C GY/ 7FX). ONCE THIS ERROR WAS DISCOVERED THE PRESCRIPTION WAS AMENDED BY THE PHYSICIAN TO DECREASE THE DOSE RATE TO 200 C GY PER FRACTION FOR THE REMAINING 8 TREATMENTS. AT COMPLETION OF THIS COURSE OF TREATMENT,THE PT WILL HAVE RECEIVED 4500 C GY GIVEN DOSE IN 15 FRACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAR ACCELERATOR LINEAR ACCELERATOR IYE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR