BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE Q7

    MDR report key: 3115662 · Received May 9, 2013

    Report

    Report Number
    2937137-2013-00008
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 8, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K973673
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) IS CURRENTLY WORKING WITH SUNRISE MEDICAL TO MAKE REPAIRS TO THE END USER'S WHEELCHAIR. (B)(6) HAS PROVIDED A LOANER WHEELCHAIR TO THE END USER UNTIL REPAIRS ARE FINISHED. 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 SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PER (B)(6) (DEALER), THE FOLDING HINGE ON THE END USER'S BACKREST SNAPPED CAUSING THE END USER TO FALL BACK IN THE CHAIR. (B)(6), SAID THAT THE END USER SUSTAINED LOWER BACK INJURIES, BUT THAT HE IS UNAWARE OF THE SEVERITY OF THE ALLEGED INJURIES. THIS COMPLAINT HAS BEEN FORWARDED TO SUNRISE MEDICAL LEGAL DEPT DUE TO THE END USER POTENTIALLY SEEKING LEGAL ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204745 QUICKIE Q7 WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC EIR4

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R