BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3781653 · Received April 30, 2014

    Report

    Report Number
    1531186-2014-01576
    Date Received
    April 30, 2014
    Report Date
    March 26, 2014
    Manufacturer
    CONSMA
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE PROVIDER STATES THE END USER WAS SITTING ON THE ROLLATOR AND THE FRAME THAT THE SEAT ATTACHES TO BROKE AT THE WELD CAUSING HER TO FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260521 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other