BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2853776 · Received December 3, 2012

    Report

    Report Number
    1525712-2012-02591
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    December 1, 2012
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL UNKNOWN, SERIAL NUMBER/DATE CODE. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    END USER STATES THAT THE WALKER IS WOBBLY AND THE BRAKES DO NOT WORK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 Other