BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3200388 · Received July 1, 2013

    Report

    Report Number
    1531186-2013-02879
    Date Received
    July 1, 2013
    Report Date
    June 5, 2013
    Manufacturer
    CONSMA
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES ON ROLLATOR MODEL 65851R LOT CODE CK120720 THAT THE RIGHT BRAKE HANDLE ASSEMBLY FELL OFF AND BROKE WHEN THE CLIENT WAS USING THE ROLLATOR. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299451 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA 65851R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other