BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHONE

    MDR report key: 410284 · Received August 1, 2002

    Report

    Report Number
    1226563-2002-00002
    Event Type
    Injury
    Date Received
    August 1, 2002
    Date of Event
    July 15, 2002
    Report Date
    July 29, 2002
    Manufacturer
    ONI, INC.
    Product Code
    LNH
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CONVERSATION BETWEEN THE HOSPITAL'S MRI TECHNOLOGIST AND ONI'S APPLICATIONS SPECIALIST, MRI TECHNOLOGIST REPORTEDLY HAD FINGERS PINCHED WHEN RETRACTING THE PT CHAIRS LEG SUPPORT. THE TECH ALSO REPORTED BRUISING AROUND THE NUCKLE. AS A RESULT OF THIS, DURING ONI'S FOLLOW-UP. THE EVENT DESCRIBED ABOVE WAS WITH REGARD TO THE PT CHAIR LOT NUMBER 000949. THE CHAIR IS PART OF THE OVERALL ORTHONE MRI SYSTEM, LOT NUMBER 002126.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHONE MRI SYSTEM LNH ONI, INC. * 002126

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other