BEUDAMED
    FDA Adverse Event Other Summary report: N

    MED-TEC, TYPE-S SYSTEM

    MDR report key: 485134 · Received July 22, 2003

    Report

    Report Number
    1932738-2003-00001
    Event Type
    Other
    Date Received
    July 22, 2003
    Date of Event
    July 15, 2003
    Report Date
    July 22, 2003
    Manufacturer
    MED-TEC,INC.
    Product Code
    IWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A PT WAS SET UP ON THE TYPE-S ON THE VARIAN EXACT COUCH. THE EXACT-BAR IS PERMANENTLY ATTACHED TO THE TYPE-S AND IT WAS ATTACHED TO THE TABLE. THE THERAPIST PUSHED ON THE EXACT-BAR TO MAKE SURE IT WAS SECURE. THE PT LAID DOWN ON THE TYPE-S, BUT PT WAS TOO HIGH, SO THEY ASKED PT TO MOVE DOWN SO THEY COULD GET THE MASK ON. WHEN PT DID THAT, PT AND THE TYPE-S FELL HEAD FIRST OFF THE HEAD END OF THE COUCH. ACCORDING TO THE THERAPIST, THE PT DID NOT HAVE ANY VISIBLE INJURIES. PT GOT UP OFF THE FLOOR BY THEMSELVES, BUT THEY SENT PT TO HAVE A CT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-TEC, TYPE-S SYSTEM CARBON FIBER HEAD, NECK, AND SHOULDER BASE IWY MED-TEC,INC. MT-CFHN-SUB2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other