BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4242240 · Received November 11, 2014

    Report

    Report Number
    9615290-2014-00166
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    September 10, 2014
    Report Date
    October 14, 2014
    Manufacturer
    DOLOMITE AB
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE LOCKING MECHANISM TYPE "COMPASS" CLOSED CAUSING THE PATIENT FALL."THE ROLLATOR ACTIO 2 IS THE SAME /SIMILAR TO A PRODUCT OR PRODUCTS WHICH ARE, OR HAVE BEEN MANUFACTURED AND/OR MARKETED BY INVACARE IN U.S. THE ALLEGED MALFUNCTION OCCURED IN EUROPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726138 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ DOLOMITE AB 1521861

    Patients

    Seq Age Sex Outcome Treatment
    1 Other