BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE QXI

    MDR report key: 4723733 · Received April 20, 2015

    Report

    Report Number
    9616084-2015-00002
    Event Type
    Injury
    Date Received
    April 20, 2015
    Date of Event
    March 25, 2015
    Report Date
    March 25, 2015
    Manufacturer
    SUNRISE MEDICAL TECHNOLGIAS S.A. DE CV
    Product Code
    IOR
    PMA / PMN Number
    K072153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARS THE WHEELCHAIR AND/OR PARTS INVOLVED IN THIS INCIDENT ARE BEING RETURNED TO SUNRISE MEDICAL. IF AND WHEN THE CHAIR/PARTS ARE RECEIVED, OUR INTERNAL FAILURE INVESTIGATOR WILL COMPLETE THE INVESTIGATION AND A FOLLOW UP WILL BE FILLED.

    Description of Event or Problem · 1

    AN ADVERSE EVENT INVOLVING A QUICKIE QXI WHEELCHAIR WAS REPORTED TO SUNRISE MEDICAL ON (B)(6) 2015. THE DEALER STATED THE LEFT FRONT CASTER STEM BOLTS CAME LOOSE CAUSING THE WHEELCHAIR TO TIP OVER. AS A RESULT THE END-USER FELL OUT OF HIS WHEELCHAIR AND SUSTAINED A BROKEN ANKLE. THE DEALER CLAIMS THE EVENT OCCURRED DURING NORMAL USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259577 QUICKIE QXI WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL TECHNOLGIAS S.A. DE CV EIF6

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention