BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3020234 · Received March 25, 2013

    Report

    Report Number
    1525712-2013-02288
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Report Date
    February 27, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED BY THE CONSUMER THAT THE UNSPECIFIED WALKER HAD TWO LOOSE SCREWS ON THE CROSSBEAM FRONT SECTION. ADDITIONALLY, IT WAS REPORTED THAT THE LEGS HAD SHARP ENDS THAT POKED THRU RUBBER TIPS ON BOTTOM OF WALKER. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121486 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 Other