BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3832591 · Received May 27, 2014

    Report

    Report Number
    1531186-2014-01977
    Date Received
    May 27, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 15, 2014
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE FRONT LEFT CASTER DOES NOT SWIVEL AND DOES NOT TURN PROPERLY. THIS LEAD TO THE END USER FALLING BACKWARDS AND JAMMING THEIR RIGHT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310787 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 65100R

    Patients

    Seq Age Sex Outcome Treatment
    1 91 MO Other