BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE Q7

    MDR report key: 3415398 · Received October 9, 2013

    Report

    Report Number
    2937137-2013-00049
    Event Type
    Injury
    Date Received
    October 9, 2013
    Date of Event
    September 25, 2013
    Report Date
    September 26, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    IOR
    PMA / PMN Number
    K123975
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    IT WAS REPORTED TO SUNRISE MEDICAL THAT ON (B)(6) 2013 AN ADVERSE EVENT INVOLVING A QUICKIE Q7 HAD OCCURRED. THE DEALER REPORTED THAT THE END USER WAS ATTEMPTING TO TRANSFER FROM HER WHEELCHAIR TO THE TOILET WHEN HER FOOT RUBBED AGAINST THE FOOTREST OF HER WHEELCHAIR. THE END USER ALLEGES THAT SHE WAS CUT ON HER FOOT AND REQUIRED STITCHES TO CLOSE THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512516 QUICKIE Q7 WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC. EIR4

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention