BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSCOE KNEE SCOOTER

    MDR report key: 5841464 · Received August 2, 2016

    Report

    Report Number
    3005182235-2016-00020
    Event Type
    Injury
    Date Received
    August 2, 2016
    Date of Event
    June 17, 2016
    Report Date
    July 24, 2019
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE ITEM NUMBER WAS OBTAINED FOR THIS REPORT. ITEM NUMBER IS ROS-KSB.

    Description of Event or Problem · 1

    THE END-USER WAS PRESCRIBED AND RENTED A KNEE SCOOTER FOR USE FOLLOWING AN INJURY TO HIS ANKLE. THE END-USER WAS WALKING INTO WORK FROM THE PARKING LOT WITH THE USE OF THE KNEE SCOOTER, WHEN THE SCOOTER HIT A SMALL CRACK IN A PORTION OF CONCRETE. THE KNEE SCOOTER WAS UNABLE TO OVERCOME THE SMALL ELEVATION CHANGE, AND STOPPED SUDDENLY AS HE BEGAN MOVING FORWARD. AS A RESULT, HE FLIPPED, AND WAS SEVERELY AND PERMANENTLY INJURED. THE USER IS REPORTED AS INCURRING HOSPITAL, DOCTOR AND MEDICAL EXPENSES, AS WELL AS LOSS OF WAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493146 ROSCOE KNEE SCOOTER KNEE SCOOTER ITJ ROS-KSB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R