BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4212420 · Received October 30, 2014

    Report

    Report Number
    1531186-2014-05210
    Date Received
    October 30, 2014
    Date of Event
    September 19, 2014
    Report Date
    October 8, 2014
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER ADVISED WHEN WALKER IS OPENED UP IN LOCKED POSITION, IT WOBBLES TWO OR THREE INCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696066 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 6291-JR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other