BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3112813 · Received May 14, 2013

    Report

    Report Number
    1531186-2013-02070
    Date Received
    May 14, 2013
    Report Date
    April 18, 2013
    Manufacturer
    CONSMA
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THE END USER IS HAVING ISSUES WITH THE RIGHT BRAKE ENGAGING. WAS NOT ABLE TO ADJUST CABLE MAY HAVE FRAYED UP INSIDE. LOT NUMBER CK120720 (SOLD (B)(6) 2012). STILL UNDER WARRANTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212313 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA 65650R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other