BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3252903 · Received July 29, 2013

    Report

    Report Number
    1531186-2013-03450
    Date Received
    July 29, 2013
    Report Date
    July 11, 2013
    Manufacturer
    CONSMA
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 65851R ROLLATOR'S LEGS BENT UNDER THE USER. THE USER FELL FORWARD CAUSING A BACK INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353547 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA 65851R

    Patients

    Seq Age Sex Outcome Treatment
    1 42 MO Required Intervention