BEUDAMED
    FDA Adverse Event Other Summary report: N

    RIFTON

    MDR report key: 2249861 · Received September 9, 2011

    Report

    Report Number
    MW5022219
    Event Type
    Other
    Date Received
    September 9, 2011
    Date of Event
    September 3, 2011
    Report Date
    September 9, 2011
    Manufacturer
    COMMUNITY PRODUCTS LLC
    Product Code
    ION
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    OUR GRANDDAUGHTER WHO HAS HAD A BRAIN TUMOR AND STROKE IS SOMEWHAT LIMITED IN HER WALKING AND USE OF RIGHT HAND. WE PURCHASED A RIFTON ADAPTIVE TRICYCLE NEW FROM THE MANUFACTURER. THE MANUAL GIVES NO WARNINGS AS TO TIPPING OF THIS TRICYCLE. OUR GRANDDAUGHTER WAS RIDING THIS DEVICE ON A SMOOTH PAVED SURFACE (UNUSED PARKING LOT) AND TIPPED OVER BY APPARENTLY TURNING THE WHEEL TOO SHARPLY AT SOME SPEED THAT ALLOWED THIS TO HAPPEN. FORTUNATELY SHE WAS WEARING A HELMET AND EXCEPT FOR A FEW SCRAPES WAS OK. WE CALLED THE COMPANY, RIFTON, AND THEY ONLY TOLD US THAT WE SHOULD PROVIDE BETTER SUPERVISION. WE HAVE SEEN VIDEO OF ANOTHER TRICYCLE COMPANY, TIDYNAMIC, THAT HAS INSTALLED A STEERING LIMITER ON THEIR TRICYCLE TO PREVENT TIPPING BY LIMITING HOW SHARPLY ONE CAN TURN THE STEERING WHEEL. OBVIOUSLY RIFTON NEEDS TO DO THE SAME BUT SO FAR IS UNWILLING TO EVEN DISCUSS SOME ALTERNATIVE TO "BETTER SUPERVISION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIFTON ADAPTIVE TRICYCLE ION COMMUNITY PRODUCTS LLC R120

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR