BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROCODILE GAIT TRAINER

    MDR report key: 3113331 · Received May 10, 2013

    Report

    Report Number
    3113331
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 10, 2013
    Manufacturer
    SNUG SEAT, INC.
    Product Code
    INN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT FELL DOWN AND BRUISED HER THIGH WHEN THE HANDLE ON HER WALKER BROKE OFF. SHE WAS IN HER HOUSE WALKING DOWN THE HALLWAY WHEN THIS HAPPENED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?GAIT THERAPY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209135 CROCODILE GAIT TRAINER CHAIR, ADJUSTABLE, MECHANICAL INN SNUG SEAT, INC. 86803 CROCODILE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR NO| NO OTHER THERAPIES