BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE

    MDR report key: 1702076 · Received May 27, 2010

    Report

    Report Number
    2937137-2010-00007
    Event Type
    Injury
    Date Received
    May 27, 2010
    Date of Event
    April 14, 2010
    Report Date
    April 29, 2010
    Manufacturer
    SUNRISE MEDICAL, INC.
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 5/3/2010, A SUNRISE SALES REP WAS CONTACTED FOR ADDITIONAL INFORMATION VIA EMAIL. THE SALES REP CALLED TO GIVE ME THE DETAILS OF THE EVENT. HE STATED HE WILL BE GOING OUT TO THE END USERS HOME IN THE NEXT WEEK OR SO TO SEE WHAT THE ISSUE IS AND EVALUATE THE CHAIR. ON 5/20/2010, THE SALES REP WAS CONTACTED VIA EMAIL TO FIND OUT THE STATUS ON HIS EVALUATION OF THE CHAIR. ON 5/24/2010, THE SALES REP WAS CONTACTED AGAIN VIA EMAIL AS TO THE STATUS AGAIN. ON 5/24/2010, THE SALES REP CALLED TO REPORT HIS FINDINGS. HE STATED THAT HE WENT TO SEE THE USER AND HIS CHAIR TO FIND OUT WHAT THE ISSUE WAS WITH THE FRONT CASTER ASSEMBLY AND POSSIBLY REPLACE WITH AN ALTERNATE STYLE PER USERS REQUEST. REP FOUND CASTERS TO BE IN GOOD CONDITION AND NO ISSUES, HOWEVER, WHEN REP EVALUATED USER IN THE CHAIR HE NOTICED THE CHAIR WAS NOT SET UP PROPERLY FOR THIS USER. HE FOUND THE CENTER OF GRAVITY WAS NOT RIGHT. THE REAR WHEELS WERE TOO FAR FORWARD AND CAUSED A FRONT LOAD ON THE CHAIR. ONCE REP MADE PROPER ADJUSTMENTS THE USER DECIDED TO KEEP THE ORIGINAL CASTER ASSEMBLY STYLE. NO FURTHER ACTION WAS NEEDED.

    Description of Event or Problem · 1

    ON (B) (6) 2010, A SUNRISE SALES REPORTED THAT A USER CONTACTED HIM ABOUT AN EVENT WITH HIS WHEELCHAIR. IT WAS REPORTED THAT THE USER WAS ROLLING ACROSS A GYM FLOOR AT A LOCAL SCHOOL WHEN HE ROLLED PAST THE ANNOUNCER AND HIT THE EXTENSION CORD RUNNING ALONG ON THE FLOOR. THIS CAUSED HIS CHAIR TO STOP QUICKLY AND TIP FORWARD. USER FELL OUT OF THE CHAIR. USER THEN WENT TO THE ER 3 DAYS LATER WHEN HE WAS DIAGNOSED WITH A LOWER END FRACTURE OF HIS RIGHT FEMUR. USER WAS NOT ABLE TO CONTACT THE DEALER WHO ORIGINALLY ORDER HIS CHAIR FOR HIM AS THEY HAD GONE OUT OF BUSINESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKIE WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL, INC. QUICKIE Q7 EIR4

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention