BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRICYCLE

    MDR report key: 787086 · Received November 22, 2006

    Report

    Report Number
    MW1041146
    Event Type
    Injury
    Date Received
    November 22, 2006
    Report Date
    November 22, 2006
    Manufacturer
    FREEDOM CONCEPT INC.
    Product Code
    ION
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IN THE 1990'S, US GOVT. STARTED PAYING FOR THIS SPECIAL ADAPTIVE TRICYCLE FOR CHILDREN WITH DISABILITIES. THIS TRICYCLE HAD QUALITY ISSUES. THE MFR IS NOT REGULATED. NOBODY IS EXPRESSING THEIR CONCERN ON THE END USER. US GOV'T NEEDS TO PLACE SOME SANCTIONS ON THESE MFRS. MY SON TIPPED OVER WHILE RIDING THIS TRICYCLE. I REPORTED IT TO THE MFR AND IT WAS REPLACED. MY SON TIPPED OVER AGAIN ON THE SECOND TRICYCLE. I FIND OUT FROM A LOT OF PARENTS WITH CHILDREN OF DISABILITY AND THEY COMPLAIN ABOUT THE SAME PROBLEM. FDA NEEDS TO INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRICYCLE * ION FREEDOM CONCEPT INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention