BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4109058 · Received September 23, 2014

    Report

    Report Number
    1531186-2014-04334
    Date Received
    September 23, 2014
    Report Date
    August 18, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ENDUSER STATES IF SHE SITS DOWN THE BRAKES ARE NOT WORKING ON THE ROLLATOR, BUT WHEN WALKING THEY APPEAR TO WORK FINE. UPDATE (B)(6) 2014 CUSTOMER STATES THE WHEEL LOCKS ARE NOT HOLDING. BRAKE ASSEMBLY 1142630 NEEDED. CUSTOMER CALLED DEALER AFTER LAST CALL INTO INVACARE AND DEALER TELLING CUSTOMER THAT BRAKES HAVE ONE YEAR WARRANTY. DEALER (B)(4). THEY CAN ONLY ORDER BUT NOT INSTALL OUT OF STATES. CUSTOMER IN (B)(6). CALLED (B)(4) FOR CUSTOMER AND ASKED IF THEY COULD ORDER WARRANTY BRAKES AND INSTALL AND HOW MUCH. THEY WILL CONTACT CUSTOMER WITH COST. ADVISED CUSTOMER TO EXPECT CALL FROM (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592427 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other