BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3202883 · Received July 2, 2013

    Report

    Report Number
    9616091-2013-01125
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 7, 2013
    Manufacturer
    INVAMEX
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THE HEIGHT ADJUSTMENT PIN HAS BROKEN OFF THE LEG OF THE 6291-5F WALKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301342 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ INVAMEX 6291-5F

    Patients

    Seq Age Sex Outcome Treatment
    1 Other