BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE Q7

    MDR report key: 3556656 · Received December 23, 2013

    Report

    Report Number
    2937137-2013-00069
    Event Type
    Injury
    Date Received
    December 23, 2013
    Date of Event
    November 4, 2013
    Report Date
    December 17, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    IOR
    PMA / PMN Number
    K123975
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 INFORMATION CAN BE OBTAINED FROM THAT INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AN ADVERSE EVENT INVOLVING A QUICKIE Q7 WHEELCHAIR WAS REPORTED TO SUNRISE MEDICAL ON (B)(6) 2013. IT IS BEING ALLEGED THAT THE WHEEL LOCKS ON THE WHEELCHAIR FAILED WHILE THE OCCUPANT WAS ATTEMPTING TO TRANSFER FROM HER BED INTO HER WHEELCHAIR. AS A RESULT, THE OCCUPANT FELL TO THE GROUND AND SUSTAINED A BROKEN TIBIA AND FIBULA IN HER RIGHT LEG. ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME DUE TO LEGAL INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672456 QUICKIE Q7 WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC. EIR4

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention