BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUAL HEAD GENESYS

    MDR report key: 375521 · Received February 1, 2002

    Report

    Report Number
    2916556-2002-00005
    Event Type
    Other
    Date Received
    February 1, 2002
    Date of Event
    December 15, 2001
    Report Date
    January 24, 2002
    Manufacturer
    ADAC LABORATORIES
    Product Code
    IXY
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO ADAC THAT A PTS HAIR WRAPPED AROUND THE LEAD SCREW SEVERAL TIMES. TECHNOLOGISTS WAS ALARMED BY THE PT AND THE EMERGENCY STOP WAS IMMEDIATELY ACTIVATED. PT'S HAIR THAT WAS ENTWINED ON THE SCREW WAS THEN CUT OFF BY THE TECHNOLOGIST. THERE WERE NO REPORTED INJURIES AS RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL HEAD GENESYS NUCLEAR MEDICINE EQUIPMENT IXY ADAC LABORATORIES 2144-3000B

    Patients

    Seq Age Sex Outcome Treatment
    1