BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2870469 · Received December 12, 2012

    Report

    Report Number
    1531186-2012-01704
    Date Received
    December 12, 2012
    Report Date
    December 10, 2012
    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

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES THE BRACKET THAT GOES FROM FRONT TO THE BACK ON THE ROLLATOR, THAT ALLOWS IT TO FOLD, THE BOLT BACKED OUT AND FELL OUT. 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 Other