BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEUS XR/A

    MDR report key: 3763427 · Received April 11, 2014

    Report

    Report Number
    9613445-2014-00102
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 14, 2014
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    KPR
    PMA / PMN Number
    K993090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BILATERAL HAND AND WRIST EXAM; AND WHILE THE TECHNOLOGIST WAS ROTATING THE COLLIMATOR FOR PT POSITIONING, THE COLLIMATOR DETACHED AND IMPACTED THE PTS WRIST RESULTING IN A FRACTURE OF THE HAMATE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220915 PROTEUS XR/A SYSTEM, X-RAY, STATIONARY KPR GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other