BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3133387 · Received May 29, 2013

    Report

    Report Number
    1531186-2013-02348
    Date Received
    May 29, 2013
    Report Date
    December 26, 2012
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVACARE AWARENESS DATE (B)(4) 2012. COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FOR PROCESSING UNTIL (B)(4) 2013.

    Description of Event or Problem · 1

    PROVIDER STATES BRAKES ARE NOT FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235219 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 65350GR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other