BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2843219 · Received November 21, 2012

    Report

    Report Number
    1531186-2012-01434
    Date Received
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    KENSTONE METAL
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES BOTH WELDS ON EITHER SIDE OF THE SEAT ARE BROKEN. THE REPORTER STATED THAT THERE WAS NO INJURY. THE DEVICE HAS BEEN REPLACED. PLEASE NOTE THAT IF ANY FURTHER INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ KENSTONE METAL 65350

    Patients

    Seq Age Sex Outcome Treatment
    1 Other