BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2844011 · Received November 23, 2012

    Report

    Report Number
    1531186-2012-01462
    Date Received
    November 23, 2012
    Date of Event
    October 25, 2012
    Report Date
    November 23, 2012
    Manufacturer
    CONSMA
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    A DEALER HAS CALLED TO REPORT THE HORIZONTAL SUPPORT BAR IN REAR RIGHT IS BROKEN. IN SPEAKING WITH THE REPORTER IT WAS LEARNED THAT THE END USER BROUGHT IN THE DEVICE WITH THE PART BROKEN. THE END USER DID NOT EXPLAIN HOW THE INCIDENT TOOK PLACE. SHE HAS NO FURTHER INCIDENT CLARIFICATION TO DISCLOSE. END USER HAS BEEN USING THE DEVICE SINCE (B)(6) 2012. END USER WAS GIVEN A NEW ROLLATOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other