BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2760001 · Received September 26, 2012

    Report

    Report Number
    1531186-2012-01021
    Date Received
    September 26, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 25, 2012
    Manufacturer
    KENSTONE METAL
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6) 2012 - NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CUSTOMER ALLEGES THAT THE LEFT REAR CASTER SPLIT IN HALF. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ KENSTONE METAL 66550

    Patients

    Seq Age Sex Outcome Treatment
    1 54 Other