BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2820018 · Received November 5, 2012

    Report

    Report Number
    1531186-2012-01338
    Date Received
    November 5, 2012
    Report Date
    November 3, 2012
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATED ROLLATOR FRAME DEFECT. ALLEGES REAR LEFT LEG BENT. FOLLOW-UP CALL REVEALED THAT USER FELL WHEN NOT USING THE WALKER. NO EXPLANATION ASSOCIATED WITH THE INCIDENT. MDR FILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 Other