BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE S646

    MDR report key: 3431120 · Received October 22, 2013

    Report

    Report Number
    2937137-2013-00054
    Event Type
    Injury
    Date Received
    October 22, 2013
    Date of Event
    April 20, 2012
    Report Date
    October 8, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    ITI
    PMA / PMN Number
    K981462
    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 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

    SUNRISE MEDICAL WAS MADE AWARE OF SUITE VIA NOTICE OF SERVICE OF PROCESS ON (B)(6) 2013 REGARDING AN INCIDENT INVOLVING A QUICKIE S646 POWER CHAIR. IT WAS REPORTED TO SUNRISE MEDICAL THAT ON (B)(6) 2012 AN END USER SUSTAINED INJURY WHILE IN HIS S646 POWER CHAIR. LEGAL DOCUMENTS ALLEGE THAT THE END USER WAS RIDING IN HIS WHEELCHAIR IN HIS FRONT YARD WHEN THE CHAIR CAME TO A SUDDEN HALT. THE END USER WAS THROWN FORWARD FROM THE CHAIR AND FELL TO GROUND AND SUFFERED A FRACTURE TO THE RIGHT DISTAL FEMUR. FURTHER INFO IS UNAVAILABLE AT THIS TIME DUE TO LEGAL INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541124 QUICKIE S646 WHEELCHAIR, POWERED ITI SUNRISE MEDICAL (US) LLC. EIS62

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention