BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4041068 · Received August 27, 2014

    Report

    Report Number
    1531186-2014-03600
    Date Received
    August 27, 2014
    Report Date
    August 4, 2014
    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

    PROVIDER STATES THE BACK SUPPORT ASSEMBLY BROKE CAUSING THE FRAME TO BEND. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522180 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ DANYANG MAXTHAI MEDICAL EQUIPMENT 65650R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other