BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMEX ROLLATOR

    MDR report key: 833993 · Received March 28, 2007

    Report

    Report Number
    MW1042436
    Event Type
    Other
    Date Received
    March 28, 2007
    Date of Event
    March 8, 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, A DME DEALER NOTIFIED GFHP, VIA TELEPHONE AND REPORTED THAT DURING USAGE, A ROLLATOR'S RIGHT FRONT WHEEL BROKE-OFF FROM THE LEG AND CAUSED THE END-USER TO FALL. AT THE TIME OF THE REPORT, IT WAS STATED BY THE DME DEALER, THAT MEDICAL ATTENTION WAS NOT SOUGHT BY THE END-USER. UPON FURTHER INVESTIGATION AND CONVERSING WITH THE END-USER, THE END-USER REPORTED THAT HE HAD GONE TO THE EMERGENCY ROOM AND RECEIVED A CAT SCAN. THE END-USER REPORTS THAT HE IS OK TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMEX ROLLATOR ROLLATOR ITJ DAN YANG JU MAO HEALTHCARE EQUIPMENT CO., LTD RJ4300B NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other