BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2844128 · Received November 24, 2012

    Report

    Report Number
    1531186-2012-01474
    Date Received
    November 24, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 24, 2012
    Manufacturer
    JUNCHENG
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE CONSUMER ALLEGEDLY FELL OR TRIPPED WITH THE 6240-5F WALKER, BREAKING THE LEG WHERE THE RIVET IS. NO ALLEGEDLY MALFUNCTION WITH THE WALKER. DEALER IS NOT SURE WHAT EXACTUALLY HAPPENED BUT CONFIRMED THAT THERE WAS NO INJURY. PRODUCT IS BEING RETURNED FOR AN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ JUNCHENG 6240-5F

    Patients

    Seq Age Sex Outcome Treatment
    1 Other