BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3935757 · Received July 15, 2014

    Report

    Report Number
    1531186-2014-02538
    Date Received
    July 15, 2014
    Report Date
    June 9, 2014
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THAT PATIENT RECEIVED ROLLATOR A YEAR AGO FROM INSURANCE. THEY WERE NOT AWARE HOW TO USE THE BRAKES. THEY CLAIM THE BRAKES DO NOT WORK. I EXPLAINED TO HAVE CUSTOMER PUSH THE BRAKE DOWNWARD SO THAT IT CLICKS IN PLACE, CUSTOMER DID NOT TRY THAT AND WILL GO TRY NOW. CUSTOMER STATES THAT PATIENT WAS HURT. SKIN IS THIN AND HE SLIPPED WHEN TRYING TO SIT, BECAUSE ROLLATOR WAS NOT LOCKED. HE SCRAPED HIS ELBOW AND WAS BANDAGED. CUSTOMER STATES IT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412601 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ DANYANG MAXTHAI MEDICAL EQUIPMENT 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other