BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3230316 · Received July 16, 2013

    Report

    Report Number
    1531186-2013-03192
    Date Received
    July 16, 2013
    Report Date
    June 26, 2013
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. THE SEAT IS CRACKED AND THE END USER FELL WHILE USING THE ROLLATOR. NO INJURY OR MEDICAL INTERVENTION WERE REPORTED.

    Description of Event or Problem · 1

    THE SEAT IS CRACKED AND THE END USER FELL WHILE USING THE ROLLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328645 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ DANYANG MAXTHAI MEDICAL EQUIPMENT 65851R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other