BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3114744 · Received May 15, 2013

    Report

    Report Number
    1531186-2013-02098
    Date Received
    May 15, 2013
    Report Date
    April 19, 2013
    Manufacturer
    KENSTONE METAL
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    KEL - 08-28-2013 - FOLLOW UP #001. INITIAL PR 65290 ISSUED MFR. REPORT # 1531186-203-02098 INDICTING THE MANUFACTURER AS UNKNOWN. THE ACTUAL MANUFACTURER IS KENMSTONE METAL. SECTIONS D3 AND F14 HAVE BEEN CORRECTED.

    Description of Event or Problem · 1

    CONSUMER STATES BOTH WHEELS ARE CRACKING - SAYS THIS HAS HAPPENED SEVERAL TIMES BEFORE AND HAS REPLACED WHEELS NUMEROUS TIMES. HAS HAD ROLLATOR FOR APPROX 8 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215123 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ KENSTONE METAL 66550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other