BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4242483 · Received November 11, 2014

    Report

    Report Number
    1531186-2014-05525
    Date Received
    November 11, 2014
    Report Date
    October 22, 2014
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES THE LEFT REAR CASTER IS WOBBLY, NOT ABLE TO TIGHTEN. DEALER STATES IT IS OUT OF BOX FAILURE. DEALER DID NOT KNOW THE PO OR ORDER NUMBER IT CAME FROM. I WAS GOING TO REPLACE THE CASTER, DEALER WANTED REPLACEMENT. EXPLAINED IT COULD NOT BE DONE WITHOUT AN ORIGINAL ORDER OR VALID PO PER ROTECH POLICY. PUT DEALER ON HOLD TO SEARCH FOR A RECENT PO AND DEALER DISCONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727885 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ DANYANG MAXTHAI MEDICAL EQUIPMENT 65650R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other