BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-ACT ROM KNEE

    MDR report key: 2903451 · Received January 4, 2013

    Report

    Report Number
    9616086-2013-00001
    Event Type
    Injury
    Date Received
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    DJO, LLC
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS GETTING OUT OF BED IN THE HOSPITAL, HE SLIPPED WITH THE BRACE ON, THE BRACE BUCKLED AND PATIENT FELL AND TORE HIS MCL. NO MODIFICATIONS WE MADE TO THE BRACE AND THE BRACE WAS LOCKED IN FULL EXTENSION. DEVICE WAS NOT RETURNED TO DJO FOR EVALUATION; BRACE WAS DISCARDED BY USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5255 X-ACT ROM KNEE RIGID KNEE BRACE IQI DJO, LLC 11-2151-9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other