BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3092831 · Received May 3, 2013

    Report

    Report Number
    1531186-2013-01899
    Date Received
    May 3, 2013
    Report Date
    April 9, 2013
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES ON ROLLATOR MODEL 65650 LOT CODE MX110715 ON ORDER (B)(4) DATED (B)(4) 2012 THAT THE RIGHT BRAKE ASSEMBLY DISINTEGRATED WHEN THE CUSTOMER WENT TO PUT THE BRAKE ASSEMBLY INTO THE LOCK POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194252 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ DANYANG MAXTHAI MEDICAL EQUIPMENT 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other