BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3202888 · Received July 2, 2013

    Report

    Report Number
    1531186-2013-02923
    Date Received
    July 2, 2013
    Report Date
    June 10, 2013
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE PROVIDER REPORTED THE FRAME ON THE 65100 ADULT ROLLITE ROLLATOR IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302680 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 65100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other