BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4040482 · Received August 27, 2014

    Report

    Report Number
    1531186-2014-03604
    Date Received
    August 27, 2014
    Date of Event
    July 22, 2014
    Report Date
    August 1, 2014
    Manufacturer
    CONSMA - CK - E. CHINA
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER REPORTS THAT FRONT LEFT WHEEL CAME OFF, STATES COMPLETELY SEPARATED FROM THE HUB. END USER FELL, AND STATES HE JUST HAD BUMPS, AND BRUISES; USER DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521464 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA - CK - E. CHINA 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other