BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4151852 · Received October 8, 2014

    Report

    Report Number
    1531186-2014-04670
    Date Received
    October 8, 2014
    Report Date
    September 16, 2014
    Manufacturer
    CONSMA
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PER END-USER THE FRAME BROKE AT THE WELD OF THIS WALKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632919 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other