BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE GTX

    MDR report key: 3082875 · Received April 18, 2013

    Report

    Report Number
    2937137-2013-00007
    Event Type
    Injury
    Date Received
    April 18, 2013
    Date of Event
    February 8, 2013
    Report Date
    April 12, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    IOR
    PMA / PMN Number
    K973673
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 OF A CHAIR OF EQUIVALENT CONSTRUCTION. IF AND WHEN MORE INFO CAN BE OBTAINED FROM THAT INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    END USER WAS IN CHAIR WHEN ALLEGEDLY THE BOLT ON THE RIGHT HAND SIDE OF THE BACKREST SHEARED OFF. THIS CAUSED THE END USER TO FALL OUT OF THE CHAIR AND INJURED HIS SHOULDER RESULTING IN A TORN ROTATOR CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167643 QUICKIE GTX WHEELCHAIR, MANUAL IOR SUNRISE MEDICAL (US) LLC. EIF3

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention