BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3747262 · Received April 12, 2014

    Report

    Report Number
    1531186-2014-01352
    Date Received
    April 12, 2014
    Report Date
    March 13, 2014
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER STATES HIS DEVICE IS MODEL NUMBER 6245, SN (B)(4). NO OTHER DESCRIPTION AVAILABLE. STATES THE DEVICE IS A WALKER WITH 2 WHEELS, 3 INCHES WITH A AXLE GOING THROUGH THEM. THE END USER STATES THE WHEELS ARE JUST GETTING WORN OVER TIME, AND WOULD LIKE TO ORDER SOME NEW ONES, SENT END USER TO PROVIDER TO EXAMINE DEVICE AND GET CORRECT PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226059 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 6245

    Patients

    Seq Age Sex Outcome Treatment
    1 Other