BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE 2 NEW

    MDR report key: 3426525 · Received October 17, 2013

    Report

    Report Number
    2937137-2013-00052
    Event Type
    Injury
    Date Received
    October 17, 2013
    Date of Event
    October 8, 2013
    Report Date
    October 8, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K123975
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    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

    AN ADVERSE EVENT WAS REPORTED TO SUNRISE MEDICAL ON (B)(6) 2013, INVOLVING A QUICKIE 2 NEW WHEELCHAIR VIA NOTICE OF SERVICE OF PROCESS. THE DOCUMENTS STATE THAT THE END USER WAS PROPELLING IN HER WHEELCHAIR FROM HER CAR TO HER HOME WHEN THE WHEELCHAIR TIPPED FORWARD THROWING THE END USER TO THE GROUND. THE END USER SUSTAINED A FRACTURE TO HER RIGHT FEMUR. ADDITIONAL INFO ISN'T AVAILABLE AT THIS TIME DUE TO LEGAL INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533165 QUICKIE 2 NEW WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC EIQ2N

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention