BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSENTIAL ROLLATOR

    MDR report key: 1395818 · Received March 31, 2009

    Report

    Report Number
    1056127-2009-00004
    Event Type
    Malfunction
    Date Received
    March 31, 2009
    Date of Event
    March 5, 2009
    Report Date
    March 6, 2009
    Manufacturer
    ESSENTIAL MEDICAL SUPPLY, INC.
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    USER WAS IN A DEPT STORE SITTING IN THE SEAT WHEN THE RIGHT CASTER DETACHED FROM THE FRAME. THE MALFUNCTION CAUSED HER TO FALL TO THE RIGHT AND ONTO THE FLOOR. NO HOSPITALIZATION WAS NECESSARY, HOWEVER THE USER DID HAVE SOME LIGHT BRUISING ON HER RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSENTIAL ROLLATOR WALKER, MECHANICAL ITJ ESSENTIAL MEDICAL SUPPLY, INC. W1700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR