BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE AFTERMARKET GROUP

    MDR report key: 5952916 · Received September 7, 2016

    Report

    Report Number
    5952916
    Event Type
    Injury
    Date Received
    September 7, 2016
    Date of Event
    September 4, 2016
    Report Date
    September 9, 2016
    Manufacturer
    UNITED PLASTIC MOLDERS, INC.
    Product Code
    KNO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SAFETY DEVICE THAT HOLDS THE NUT IN PLACE THAT CONNECTS BRAKES TO WHEELCHAIR DID NOT KEEP NUT IN PLACE DESPITE FOLLOWING MANUFACTURER'S INSTALLATION INSTRUCTIONS. POSITION OF BOLT ALLOWS TORQUE FROM BRAKES TO LOOSEN NUT BEYOND THE POSITIONING OF THE SAFETY CAP THAT COVERS THE NUT. WHEEL FELL OFF WHEELCHAIR CAUSING FALL WITH HEAD INJURY. ALL OF THESE SAME BRAKES ARE REMOVED FROM OTHER WHEELCHAIRS. UPON REMOVAL OF THESE SAME BRAKES FROM OTHER WHEELCHAIRS, THE NUT WAS LOOSE BEHIND EACH OF THE ORANGE SAFETY CAPS. IT APPEARS THAT THE ORANGE SAFETY CAP COVERS APPROXIMATELY 1/4 INCH OR LESS OF THE BOLT AND THE TORQUE FROM BRAKING RESULTS IN A LOOSENED NUT WITH THAT DOESN'T ENGAGE THE 1/4 INCH OF PROTECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586313 THE AFTERMARKET GROUP SECURE AUTOMATIC WHEEL LOCK KIT KNO UNITED PLASTIC MOLDERS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| L