BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3033881 · Received April 3, 2013

    Report

    Report Number
    1531186-2013-01390
    Date Received
    April 3, 2013
    Report Date
    March 7, 2013
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES CONSUMER WAS USING THE ROLLATOR IN THE SNOW. AS SHE WAS WALKING, THE LEFT FRONT CASTER BROKE ALL THE WAY INTO THE HOUSING, STEM BOLT AND EVERYTHING. THE WOMAN FELL FORWARD ALONG WITH THE ROLLATOR AND BROKE HER TOOTH. UPDATE: (B)(4) 2013 (B)(6) 3:06PM - END USER'S DAUGHTER STATED THAT THEY PICKED OUT THIS TYPE OF WALKER BECAUSE IT HAS THE BIGGER CASTERS DUE TO LIVING IN (B)(6). IT WOULD BE EASIER TO PUSH THROUGH SNOW OR GRASSY AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136673 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 68100

    Patients

    Seq Age Sex Outcome Treatment
    1 84 MO Other