BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPPIE ZONE

    MDR report key: 2516547 · Received March 29, 2012

    Report

    Report Number
    2937137-2012-00008
    Event Type
    Injury
    Date Received
    March 29, 2012
    Date of Event
    March 25, 2012
    Report Date
    March 26, 2012
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    IOR
    PMA / PMN Number
    K973673
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SALES REP FOR SUNRISE MEDICAL (US) LLC., STATED THAT THE PHYSICIAN WANTED TO ORDER AN 8 OR 9 INCH DEPTH ON THE SEAT, HOWEVER, DUE TO STATE REGULATIONS, THEY WERE FORCED TO ORDER A 16 INCH DEPTH TO ALLOW FOR GROWTH. IT IS POSSIBLE THAT THIS DEPTH DIFFERENCE HAS CAUSED THE CENTER OF GRAVITY ON THE WHEELCHAIR TO BE OFF, LEADING TO THE TIPPING ISSUE. THE CHAIR IS CURRENTLY WITH THE DEALER TO MAKE NECESSARY ADJUSTMENTS FOR CENTER OF GRAVITY. THE CHAIR WILL NOT BE RETURNED TO SUNRISE MEDICAL (US) LLC. PER THE QUALITY DEPARTMENT, THIS IS NOT A MANUFACTURER DEFECT, BUT A SETUP ISSUE, WHICH IS IN THE HANDS OF THE DEALER AND PHYSICIAN TO CORRECT NOW. NO FURTHER INVESTIGATION WILL BE DONE, THIS ISSUE IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    END USER WAS ROLLING ON SIDEWALK WHEN THE FRONT OF THE CHAIR TIPPED FORWARD AND HE FELL TO THE GROUND, CUTTING HIS CHIN AND CAUSING SWELLING IN HIS JAWBONE. HE ALSO GOT A BUMP ON HIS FOREHEAD. END USER WENT TO THE ER WHERE GLUE WAS APPLIED TO THE CUT ON THE CHIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIPPIE ZONE WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC. EIRZ1

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention