BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE Q7

    MDR report key: 3426514 · Received October 17, 2013

    Report

    Report Number
    2937137-2013-00053
    Event Type
    Injury
    Date Received
    October 17, 2013
    Report Date
    October 10, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K123975
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO CONTACT THE DEALER HAVE BEEN MADE TO OBTAIN MORE INFO IN REGARDS TO THIS INCIDENT. MEDICAL IS MADE AWARE OF ADDITIONAL INFO, A SUPPLEMENTAL REPORT WILL BE FILED. 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) 201,3 INVOLVING A QUICKIE Q7 WHEELCHAIR. IT WAS REPORTED THAT THE END USER WAS AT SCHOOL IN HER WHEELCHAIR WHEN SHE FELL DOWN SOME STAIRS. THE END USER SUSTAINED A FRACTURE TO HER SKULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532257 QUICKIE Q7 WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC EIR4

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention