BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3910213 · Received July 2, 2014

    Report

    Report Number
    1531186-2014-02326
    Date Received
    July 2, 2014
    Report Date
    May 30, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER CALLED IN AND STATED THAT THERE IS A SCREW THAT GOES ON AT THE END OF THE ARM OF THE ROLLATOR THAT HAS A CAP THAT ATTACHES TO COVER UP THE SCREW. DEALER STATED THE CAP OFTEN FALLS OFF RESULTING IN THE CONSUMER BEING SCRATCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386673 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 66550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other