BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3133182 · Received May 29, 2013

    Report

    Report Number
    1531186-2013-02336
    Date Received
    May 29, 2013
    Report Date
    December 11, 2012
    Manufacturer
    KENSTONE METAL
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FROM CUSTOMER SERVICE FOR PROCESSING UNTIL ((B)(4) 2013). POTENTIAL FOR INJURY ASSOCIATED WITH A BROKEN CASTER ON A 66550 BARIATRIC ROLLATOR. THIS CAN CAUSE INSTABILITY WITH THE PRODUCT AND POTENTIAL FOR END USER TO FALL.

    Description of Event or Problem · 1

    THE DEALER STATES THE CASTER IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234966 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ KENSTONE METAL 66550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other