BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4090421 · Received September 15, 2014

    Report

    Report Number
    1531186-2014-04121
    Date Received
    September 15, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 28, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER STATED THE CASTER WHEEL ON THEIR 65650 ROLLATOR IS VERY WOBBLY, THE PLASTIC LOOKED WARPED. USER FELL, INJURED RIGHT KNEE, NO MEDICAL ATTENTION SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568777 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other