BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3840338 · Received May 30, 2014

    Report

    Report Number
    1531186-2014-02013
    Date Received
    May 30, 2014
    Date of Event
    April 12, 2014
    Report Date
    April 17, 2014
    Manufacturer
    CONSMA
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    END USER FELL AND ROLLATOR FRAME BROKE AT LEG ON THE 65650R ROLLATOR. IT IS NOT CLEAR IF THE END USER FELL AND BROKE ROLLATOR DURING THE FALL OR IF THE ROLLATOR CAUSED THE END USER TO FALL. IT WAS REPORTED THAT END USER SCRAPED BACK BUT DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317968 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA 65650R

    Patients

    Seq Age Sex Outcome Treatment
    1 55 MO Other