BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMMAMED

    MDR report key: 475267 · Received July 29, 2003

    Report

    Report Number
    2914292-2003-00005
    Event Type
    Injury
    Date Received
    July 29, 2003
    Date of Event
    June 9, 2003
    Report Date
    July 29, 2003
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    JAQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    A PATIENT PRESCRIBED BRACHYTHERAPY FOR CANCER OF THE LEFT BREAST, RECEIVED A DOSE OF RADIATION TO A SITE OTHER THAN THE INTENDED SITE. THE TREATMENT PLAN WAS FOR TEN FRACTIONS OF HDR TO BE DELIVERED STARTING IN 2003. IN JUNE, 2003 BETWEEN THE 5TH AND 6TH FRACTION IT WAS DISCOVERED BY THE USER THAT THE SOURCE WAS INCORRECTLY PLACED IN THE CATHETER. THE INCORRECT PLACEMENT OF THE SOURCE IN THE CATHETER RESULTED IN A SUPERFICIAL SKIN DOSE OF 70 GY TO A CIRCULAR AREA APPROXIMATELY 1 CM IN DIAMETER. DEEPER ABSORBED DOSES OF 34 GY, 15 GY, AND 10 GY HAVE BEEN ESTIMATED BY THE USER TO BE AT DEPTHS OF 1 CM, 2 CM, AND 3 CM RESPECTIVELY. IN JUNE, 2003 THE USER OBSERVED A SLIGHT ERYTHEMA OF THE SKIN WHICH MEASURED 1 TO 2 CM IN DIAMETER. ACCORDING TO A STATEMENT OF THE USER, THE EVENT WAS A RESULT OF A HUMAN ERROR THAT OCCURRED. BY ENTERING THE WRONG STEPSIZE THE SOURCE WAS INSTRUCTED TO STOP 20CM FROM THE CATHETER TIP INSTEAD OF 20 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMAMED HIGH DOSE RATE AFTERLOADER / BRACHYTHERAPY JAQ VARIAN MEDICAL SYSTEMS, INC. PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other| R