BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3123280 · Received May 21, 2013

    Report

    Report Number
    1531186-2013-02218
    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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A 65650 ROLLATOR WHERE THE PINS WHICH LOCK THE BACK SUPPORT INTO PLACE ARE BROKEN AND THE SEAT WILL NOT LOCK. THIS ISSUE CAUSES PRODUCT INSTABILITY AND THE USER COULD FALL OFF THE SEAT AND BE INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224588 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other