BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERATRON

    MDR report key: 375707 · Received January 28, 2002

    Report

    Report Number
    8022247-2002-00008
    Event Type
    Other
    Date Received
    January 28, 2002
    Date of Event
    December 21, 2001
    Report Date
    January 24, 2002
    Manufacturer
    MDS NORDION
    Product Code
    IWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A COLLISION OCCURRED BETWEEN THE GANTRY ARM OF THE UNIT AND THE TREATMENT TABLE. BASED ON INFORMATION RECEIVED, THE COLLISION WAS THE RESULT OF OPERATOR ERROR. THERE WAS NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERATRON COLBALT THERAPY DEVICE IWB MDS NORDION ELITE 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other