BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3160646 · Received June 10, 2013

    Report

    Report Number
    1531186-2013-02528
    Date Received
    June 10, 2013
    Report Date
    May 14, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATES THAT THE SCREWS FELL OUT OF THE SEAT ON THE ROLLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259500 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 65851R

    Patients

    Seq Age Sex Outcome Treatment
    1 32 Other