BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHONE

    MDR report key: 402328 · Received June 28, 2002

    Report

    Report Number
    1226563-2002-00001
    Event Type
    Injury
    Date Received
    June 28, 2002
    Date of Event
    June 9, 2002
    Report Date
    June 11, 2002
    Manufacturer
    ONI, INC.
    Product Code
    LNH
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT THE END OF THEIR SHIFT, PATIENT WAS PERFORMING THE NIGHTLY CLOSING DUTIES. WHILE CLEANING UP THE ORTHONE SCREENING ROOM, PATIENT WAS TUCKING AWAY THE LEG REST TO THE PATIENT CHAIR, SLAMMING BOTH RIGHT AND LEFT HANDS BETWEEN THE SEAT AND LEG REST PORTIONS OF THE CHAIR, INJURING BOTH HANDS. X-RAYS WERE TAKEN, RESULTS WERE NEGATIVE FOR BROKEN BONES. CURRENTLY THEIR LEFT 1ST & 2ND DIGITS ARE A LITTLE SWOLLEN, WHILE THEIR RIGHT 1ST & 2ND DIGITS ARE BRUISED/SWOLLEN WITH CUTS TO THE KNUCKLES. FINGERS ARE TAPED/SPLINTED TOGETHER. THE EVENT DESCRIBED ABOVE WAS WITH REGARD TO THE PATIENT CHAIR (2006-00; LOT NUMBER 002348). THE CHAIR IS PART OF THE OVERALL ORTHONE MRI SYSTEM (2000-000; LOT NUMBER 002308).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHONE MRI SYSTEM LNH ONI, INC. * 002308

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other