BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4060811 · Received September 4, 2014

    Report

    Report Number
    1531186-2014-03820
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Report Date
    July 31, 2014
    Manufacturer
    CONSMA - CK - E. CHINA
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    TBM CALLED IN AND STATED THAT THE BEARINGS ON THE FRONT RIGHT CASTER OF THE ROLLATOR ARE WORN OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540372 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA - CK - E. CHINA 65650R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other