BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4132956 · Received October 1, 2014

    Report

    Report Number
    1531186-2014-04612
    Date Received
    October 1, 2014
    Report Date
    September 11, 2014
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATES THAT THE ADJUSTMENT HOLES THAT THE SNAP BUTTON GOES THROUGH ON THE REAR LEGS TO KEEP THE REAR LEGS EVEN WITH THE FRONT LEGS OVER TIME WILL OVAL OUT INSTEAD OF STAYING IN A CIRCLE SHAPE. CONSUMER STATES THAT WHEN THIS HAPPENS THE REAR LEGS ARE NO LONGER LEVEL WITH THE FRONT LEGS WHICH MAKES THE ROLLATOR HARD TO USE BECAUSE INSTEAD OF ROLLING IT HE HAS TO PICK IT UP WITH EVERY STEP TO GET IT TO WALK STRAIGHT. CONSUMER STATES THAT WHEN THIS SITUATION HAPPENS IT AFFECTS THE WHEELS AND THE AXLE OF THE WHEELS TO WEAR DOWN AT AN ACCELERATED RATE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613305 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 68100-TA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other