BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE S646

    MDR report key: 2715528 · Received August 21, 2012

    Report

    Report Number
    2937137-2012-00017
    Event Type
    Injury
    Date Received
    August 21, 2012
    Date of Event
    July 14, 2012
    Report Date
    July 23, 2012
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    ITI
    PMA / PMN Number
    K981462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE WHEELCHAIR INVOLVED IN THIS INCIDENT HAS BEEN RETURNED TO SUNRISE MEDICAL (US) LLC. THE WHEELCHAIR IS CURRENTLY UNDER INVESTIGATION BY OUR INTERNAL FAILURE INVESTIGATOR AND A MEMBER OF THE ENGINEERING DEPARTMENT. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE END USER WENT TO A HIKE AND BIKE TRAIL AND WAS PARKED AT THE EDGE OF A DROP-OFF WHEN HE ENGAGED THE JOYSTICK AND THE CHAIR WENT BACKWARDS. THE CHAIR FELL OVER SIDEWAYS. THE END USER UNBUCKLED HIMSELF FROM THE WHEELCHAIR AND FELL INTO THE CREEK THREE FEET FROM THE WHEELCHAIR. THE END USER HIT HIS HEAD AND NEEDED FOUR STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKIE S646 WHEELCHAIR, POWER ITI SUNRISE MEDICAL (US) LLC. EIS62

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention