BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2843241 · Received November 21, 2012

    Report

    Report Number
    1531186-2012-01437
    Date Received
    November 21, 2012
    Date of Event
    October 23, 2012
    Report Date
    November 21, 2012
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6) 2012. NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES THAT THE BRAKE LEVERS HAVE SNAPPED. MDR FILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other