BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3123153 · Received May 21, 2013

    Report

    Report Number
    1531186-2013-02195
    Date Received
    May 21, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 25, 2013
    Manufacturer
    CONSMA
    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

    END USER WAS INJURED WHEN THE BRAKES FAILED ON A MODEL 65650 ROLLATOR. END USER HAD ENGAGED BRAKES BUT WHEN HE WENT TO SIT ON THE SEAT, THE BRAKES FAILED, CAUSING THE ROLLATOR TO ROLL AWAY. END USER SUSTAINED BRUISING. NO REPORT OF MEDICAL INTERVENTION. WILL UPDATE IF MORE INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225085 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other