BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2960080 · Received February 13, 2013

    Report

    Report Number
    1531186-2013-00588
    Date Received
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER SAYS THE DEVICE WAS NOT BROKE, BUT ONCE THE PATIENT SAT IN IT , IT CRACKED. HE STATES THE PATIENT IS UNDER THE WEIGHT CAP. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62301 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other