BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMEX ROLLATOR

    MDR report key: 829326 · Received March 13, 2007

    Report

    Report Number
    MW1042232
    Event Type
    Other
    Date Received
    March 13, 2007
    Date of Event
    October 16, 2006
    Report Date
    March 13, 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 10/16/06, A REPORT WAS CALLEN IN, VIA TELEPHONE FROM A DEALER REGARDING AN ALLEGED END-USER INCIDENT INVOLVING A LUMEX ROLLATOR. DUE TO HIPAA LAWS END-USER CONTACT WAS NOT POSSIBLE. PER THE DEALER'S ACCOUNT, THE CUSTOMER BOUGHT THE ROLLATOR ONE YEAR BACK. THE GRANDDAUGHTER REPORTED TO THE DEALER THAT "SOMEHOW ONE OF THE WHEELS HAD UNSCREWED ITSELF AND WHEN THE LADY SAT ON IT, IT FELL OVER." PER THE GRANDFATHER, THE LADY WAS INJURED AND WENT TO THE HOSP. NO FURTHER INFO IS AVAILABE ON THE END-USER OR THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMEX ROLLATOR ROLLATOR ITJ DAN YANG JU MAO HEALTHCARE EQUIPMENT CO., LTD. RJ4300G 17386

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other