BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4120573 · Received September 26, 2014

    Report

    Report Number
    1531186-2014-04473
    Date Received
    September 26, 2014
    Report Date
    September 4, 2014
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PER END-USER, THE BACK LEFT WHEEL IS BROKEN, THE PUSH PIN IS UNSTABLE TO ADJUST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600395 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 65100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other