BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3811759 · Received May 15, 2014

    Report

    Report Number
    1531186-2014-01789
    Date Received
    May 15, 2014
    Report Date
    April 4, 2014
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES FRONT LEFT LEG ASSEMBLY IS BENT AT THE THREAD THAT SCREWS THE CASTER INTO THE FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289304 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 65100-JR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other