BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3123231 · Received May 21, 2013

    Report

    Report Number
    1531186-2013-02205
    Date Received
    May 21, 2013
    Report Date
    April 25, 2013
    Manufacturer
    CONSMA
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER ALLEGES THAT WHERE SEAT COMES TOGETHER AND ATTACHES TO HANDLES AT THE WELD BROKE. CAN NOT SIT ANY FURTHER BECAUSE IT IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224433 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 80 Other