BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2970588 · Received February 20, 2013

    Report

    Report Number
    1531186-2013-00665
    Date Received
    February 20, 2013
    Report Date
    February 19, 2013
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFG. REPORT # 1531186-2013-00665 INDICATING THE MANUFACTURER TO BE MAXTEC, INC. THE CORRECT MANUFACTURER IS DANYANG MAXTHAI MEDICAL EQUIPMENT.

    Description of Event or Problem · 1

    IVC REP RECEIVED A LETTER FROM END USER AND FOLLOWED UP WITH A PHONE CALL. END USER STATES THAT WHEN HE APPLIES THE BRAKES, THEY DO NOT STOP THE ROLLATOR ALL THE WAY. HE SAID IT APPEARS THE BRAKE DOES NOT REACH THE WHEEL ALL THE WAY, PREVENTING IT FROM STOPPING THE WHEEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74389 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ DANYANG MAXTHAI MEDICAL EQUIPMENT 65650R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other