BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLDEN COMPASS SPORT

    MDR report key: 3637025 · Received February 14, 2014

    Report

    Report Number
    2523955-2014-00003
    Event Type
    Injury
    Date Received
    February 14, 2014
    Date of Event
    December 15, 2013
    Report Date
    April 14, 2014
    Manufacturer
    GOLDEN TECHNOLOGIES, INC.
    Product Code
    ITI
    PMA / PMN Number
    041341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEALER EVALUATED WHEELCHAIR AND FOUND NO DEFECTS. UNIT IS TO BE RETURNED TO GOLDEN TECHNOLOGIES FOR FURTHER EVAL.

    Description of Event or Problem · 1

    ON MONDAY, (B)(6) 2014, THE DEALER WAS MADE AWARE ON AN INCIDENT WITH A GOLDEN TECH COMPASS SPORT (SN: (B)(4)) THAT WAS SOLD IN (B)(4) OF 2011. ON (B)(6) 2013, THE CUSTOMER WAS DRIVING THE POWER WHEELCHAIR WHILE SHOPPING AT A LOCAL MALL, STOPPED TO LOOK AT SOMETHING AND STOOP UP OUT OF THE WHEELCHAIR. THE WHEELCHAIR BEGAN TO DRIVE FORWARD AND ACTUALLY UP AND ONTO THE CUSTOMER AS SHE FELL TO THE GROUND. IT IS UNCLEAR WHETHER THIS WAS A MALFUNCTION OF THE CHAIR OR DRIVER ERROR. THE WHEELCHAIR CAUGHT HER JUST ABOVE THE ANKLE AND CUT HER LEG SEVERAL INCHES IN LENGTH AND WIDTH. THE WOUND ACTUALLY SEVERED AN ARTERY, ACCORDING TO THE FAMILY, AND SHE WAS TRANSFERRED FROM ONE HOSPITAL ER TO ANOTHER FOR EMERGENCY SURGERY. SHE SPENT A WEEK IN THE HOSP AND A SECOND WEEK IN A NURSING HOME AND IS CURRENTLY AT HOME AND IS BEING FOLLOWED BY A WOUND CARE PHYSICIAN. IT SOUNDS LIKE SHE IS ON A WOUND VACUUM PUMP AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97904 GOLDEN COMPASS SPORT WHEELCHAIR ITI GOLDEN TECHNOLOGIES, INC. GP605

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization