BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3133102 · Received May 29, 2013

    Report

    Report Number
    1531186-2013-02335
    Date Received
    May 29, 2013
    Report Date
    December 10, 2012
    Manufacturer
    CONSMA
    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). COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FROM CUSTOMER SERVICE FOR PROCESSING UNTIL ((B)(4) 2013). POTENTIAL FOR INJURY ASSOCIATED WITH THE BACK BEING BROKEN ON A 65650 ROLLATOR. THIS CAN CAUSE INSTABILITY WITH THE PRODUCT AND POTENTIAL FOR END USER TO FALL.

    Description of Event or Problem · 1

    THE DEALER STATES THAT THE BACK SUPPORT ASSEMBLY WAS BROKEN AND THEY REPLACED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237515 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ CONSMA 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other