BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2506285 · Received March 27, 2012

    Report

    Report Number
    1531186-2012-00068
    Date Received
    March 27, 2012
    Date of Event
    January 7, 2012
    Report Date
    March 27, 2012
    Manufacturer
    GENTEEL (MAXHEALTH)
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER SITTING ON THE ROLLATOR WHEN THE LEFT FRONT WHEEL ALLEGEDLY COLLAPSED. CONSUMER SUSTAINED A BROKEN RIGHT HUMERUS AND WENT TO THE EMERGENCY ROOM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other