BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3061174 · Received April 16, 2013

    Report

    Report Number
    1531186-2013-01571
    Date Received
    April 16, 2013
    Report Date
    March 20, 2013
    Manufacturer
    CONSMA
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH THE MALFUNCTIONING BRAKE ON A MODEL 65851B ROLLATOR. THIS CAN CAUSE INSTABILITY TO THE PRODUCT AND A FALLS RISK TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163476 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA 65851B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other