BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE FREESTYLE

    MDR report key: 3161568 · Received May 6, 2013

    Report

    Report Number
    2937137-2013-00012
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    September 10, 2010
    Report Date
    May 8, 2012
    Manufacturer
    SUNRISE MEDICAL
    Product Code
    ITI
    PMA / PMN Number
    K031289
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARS THAT THE WHEELCHAIR AND/OR PARTS INVOLVED IN THIS INCIDENT ARE NOT BEING RETURNED TO SUNRISE MEDICAL (US) LLC. WE WILL MAKE EVERY EFFORT TO COMPLETE AN INVESTIGATION THROUGH EITHER OBTAINING PICTURES OR VIDEO OF THE CHAIR INVOLVED, OR BY PERFORMING AN INVESTIGATION ON A CHAIR OF EQUIVALENT CONSTRUCTION. IF AND WHEN MORE INFO CAN BE OBTAINED FROM THAT INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SCHOOL TEACHER THAT HER STUDENT'S FREESTYLE POWER CHAIR UNCONTROLLABLY FLEW ACROSS THE ROOM. THE TEACHER CLAIMS THAT SHE TRIED TO SHUT THE CHAIR OFF WHILE IT WAS IN MOTION AND THE CHAIR PLOWED INTO HER, CAUSING HER TO BE THROWN AGAINST THE WALL. THE TEACHER ALLEGEDLY SUFFERED INJURY TO HER NECK AND ROTATOR CUFF. THIS INCIDENT IS BEING HANDLED BY SUNRISE MEDICAL LEGAL DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196722 QUICKIE FREESTYLE WHEELCHAIR, POWER ITI SUNRISE MEDICAL EIPW9

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention