BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4211452 · Received October 29, 2014

    Report

    Report Number
    1531186-2014-05163
    Date Received
    October 29, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER ALLEGES THE BRAKES ARE NOT HOLDING ON A (B)(4) ROLLATOR. HE HAS TRIED TIGHTENING THEM AND NEITHER SIDE WILL HOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693207 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 65100R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other