BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4240649 · Received November 10, 2014

    Report

    Report Number
    1525712-2014-07765
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 21, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER ALLEGES THAT SHE WAS SITTING ON THE SEAT AND THE RIGHT TAB THAT LOCKS THE SEAT TO THE FRAME BROKE ON A UNKNOWN WALKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724053 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other