BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRECISE DIGITAL ACCELERATOR

    MDR report key: 646908 · Received November 16, 2005

    Report

    Report Number
    9617016-2005-00013
    Event Type
    Other
    Date Received
    November 16, 2005
    Date of Event
    October 14, 2005
    Report Date
    November 15, 2005
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING THE TREATMENT THE ACCESSORY FITTED TO THE TUBE APPLICATOR FELL DOWN ON THE PT'S FACE, THE PT WAS INJURED UNDER THE EYE, CHEEKBONE. INJURY NOT SEVERE - THE CUSTOMER CONSIDERED THAT THE CAUSE WAS INCORRECT ATTACHMENT BY THE OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE DIGITAL ACCELERATOR LINEAR ACCELERATOR IYE ELEKTA LIMITED * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other