BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3981036 · Received August 5, 2014

    Report

    Report Number
    1531186-2014-02993
    Date Received
    August 5, 2014
    Report Date
    June 30, 2014
    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

    IT WAS REPORTED THAT THE FRAME BROKE ON THE RIGHT REAR WHEEL CAUSING THE WHEEL TO FALL OFF. THERE WERE NO REPORTS OF ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456896 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA 65350GR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other