BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMEX ROLLATOR

    MDR report key: 834003 · Received March 28, 2007

    Report

    Report Number
    MW1042435
    Event Type
    Other
    Date Received
    March 28, 2007
    Date of Event
    February 16, 2007
    Report Date
    March 28, 2007
    Manufacturer
    DAN YANG JU MAO HEALTHCARE EQUIPMENT CO., LTD
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 2007, THE END-USER'S ATTORNEY NOTIFIED GFHP, VIA US MAIL, AND REPORTED THAT DURING USAGE, THE RIGHT FROM WHEEL SEPARATED FROM THE LEG. THE ATTORNEY ALLEGES THAT THE END-USER FLIPPED OVER AND STRUCK HER HEAD. THE END-USER WAS TAKEN TO THE LOCAL EMERGENCY ROOM AND ADMITTED FOR OBSERVATION. THE ATTORNEY ALSO ALLEGES THAT A PHYSICAL THERAPIST, WHO WAS ASSIGNED TO HELP AND END-USER, ALSO FLIPPED OVER ON THE REPLACEMENT ROLLATOR, DUE TO A FRONT WHEEL SEPARATING FROM THE LEG. THE SECOND INCIDENT COULD NOT BE CORROBORATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMEX ROLLATOR ROLLATOR ITJ DAN YANG JU MAO HEALTHCARE EQUIPMENT CO., LTD RJ4400K M060505

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other