BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMEX ROLLATOR

    MDR report key: 829760 · Received March 14, 2007

    Report

    Report Number
    MW1042252
    Event Type
    Other
    Date Received
    March 14, 2007
    Date of Event
    September 27, 2006
    Report Date
    March 12, 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 09/27/06, A REPORT WAS CALLED IN, VIA TELEPHONE FROM A DEALER REGARDING AN ALLEGED END-USER INCIDENT INVOLVING A LUMEX ROLLATOR. THE END-USER WAS INTERIEWED, VIA TELEPHONE. PER THE END-USER'S ACCOUNT, THE LEFT FRONT WHEEL CAME OFF DURING USE. WHEN THE WHEEL CAME OFF, THE END-USER FELL FORWARD AND FELL ACROSS HER DISHWASHER. THERE WERE NO WITNESSES. NO PERMANENT INJURY WAS EXPRESSED, ONLY BRUISING AND MUSCLE STRAIN, BUT THE END-USER ALLEGES PAIN TO THE RIGHT SIDE OF HER LEG AND HIP. THE END-USER SOUGHT MEDICAL ATTENTION AT THE EMERGENCY ROOM. END-USER SUFFERS FROM BACK INJURY RELATED TO A WORKMAN'S COMPENSATION CASE CLAIM.

    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 1738

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other