BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMEX ROLLATOR

    MDR report key: 830855 · Received March 20, 2007

    Report

    Report Number
    MW1042301
    Event Type
    Other
    Date Received
    March 20, 2007
    Date of Event
    January 4, 2007
    Report Date
    March 19, 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

    IN 2007, END-USER CALLED IN, VIA TELEPHONE, REPORTING RIGHT REAR WHEEL (FROM SITTING POSITION) BOLT HAD STRIPPED, CAUSING THE WHEEL TO COME APART FROM THE ROLLATOR. IN TURN, THE END-USER ALLEGES THAT SHE FELL AND RECEIVED INJURIES. END-USER REPORTED THAT SHE RECEIVED MEDICAL ATTENTION AT LOCAL EMERGENCY ROOM. END-USER REPORTED CONTUSION AND BRUISING FROM THE HIP TO THE LEG.

    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 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other