BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4182072 · Received October 17, 2014

    Report

    Report Number
    1531186-2014-04935
    Date Received
    October 17, 2014
    Report Date
    September 26, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE (B)(4) WALKER WHEELS AND THE LEFT BOLT OR SOMETHING CAME OUT WHILE WALKING AND CUSTOMER ALMOST FELL. WHEEL IS WOBBLY. WALKER WENT FORWARD WHEN SHE ALMOST FELL AND THEN CUSTOMER NOTICED THAT THE LEFT HAND SIDE LOCKING MECHANISM IS NOT LOCKING ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661142 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 6441-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other