BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3071989 · Received April 22, 2013

    Report

    Report Number
    1531186-2013-01705
    Date Received
    April 22, 2013
    Report Date
    March 28, 2013
    Manufacturer
    CONSMA
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A BROKEN SEAT ON AN UNKNOWN ROLLATOR. THIS CREATES THE POTENTIAL FOR A FALLING INJURY TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171321 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other