BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2973261 · Received February 21, 2013

    Report

    Report Number
    1531186-2013-00718
    Date Received
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES LEFT SIDE LEG ADJUSTMENT BUTTON IS OFF CENTERED AND IT IS CAUSING WHEELS TO TURN OUTWARD. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77481 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 6281-JR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other