BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3073613 · Received April 23, 2013

    Report

    Report Number
    1531186-2013-01721
    Date Received
    April 23, 2013
    Report Date
    March 28, 2013
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE WHEEL IS TORN ON THE ROLLATOR. THIS ISSUE COULD CAUSE THE USER TO FALL BECAUSE OF ERRATIC/UNINTENDED MOVEMENT AS THE ROLLATOR WOULD BECOME UNSTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173602 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 65100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other