BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE Q7

    MDR report key: 3640724 · Received January 14, 2014

    Report

    Report Number
    2937137-2014-00004
    Event Type
    Injury
    Date Received
    January 14, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 30, 2014
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K123975
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE WORKING WITH THE DEALER TO OBTAIN THE PARTS INVOLVED IN THIS INCIDENT SO THAT AN INTERNAL INVESTIGATOR CAN PERFORM AN EVAL. IT APPEARS THAT THE WHEELCHAIR AND/OR PARTS INVOLVED IN THIS INCIDENT ARE NOT BEING RETURNED TO (B)(4). 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 F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AN ADVERSE EVENT INVOLVING A QUICKIE Q7 WAS REPORTED TO A SUNRISE SALES REP ON (B)(6) 2014. IT IS BEING ALLEGED THAT THE LEFT CASTER AND FORK SPLINE ASSEMBLY SHIFTED WHILE THE END USER WAS IN THE WHEELCHAIR. THE DEALER REPORTED THAT THIS MALFUNCTION CAUSED THE END USER TO FALL OUT OF HER CHAIR AND SUSTAIN A BROKEN LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36665 QUICKIE Q7 WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC EIR4

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention