BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMEX ROLLATOR

    MDR report key: 758152 · Received August 11, 2006

    Report

    Report Number
    MW1040337
    Event Type
    Other
    Date Received
    August 11, 2006
    Date of Event
    August 7, 2006
    Report Date
    August 11, 2006
    Manufacturer
    DAN YANG JU MAO HEALTHCARE EQUIPMENT CO., LTD.
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 08/09/06, A REPORT WAS CALLED IN, VIA TELEPHONE FROM A DEALER, MID-ATLANTIC, REGARDING AN ALLEGED END USER INCIDENT INVOLVING A LUMEX ROLLATOR. ON 08/10/06, THE END USER WAS INTERVIEWED, VIA TELEPHONE. PER THE END USER'S ACCOUNT, SHE WAS SITTING ON HER ROLLATOR WHILE SHE WORKED IN HER GARDEN. AS SHE STOOD UP FROM HER ROLLATOR, BY USING THE HANDLES, ONE OF THE HANDLES SLIPPED DOWNWARD, CAUSING THE END-USER TO FALL ON THE CONCRETE. THE END-USER REPORTED, THAT PRIOR TO THE INCIDENT, SHE HAD NOTICED THAT THE KNOB THAT HOLDS THE HANDLE ASSEMBLY IN PLACE WAS LOOSE AND WOBBLY. THE END-USER ALLEGES THAT UPON CLOSER INSPECTION, IT WAS NOTICED THAT THE BOLT THAT ATTACHES TO THE KNOB WAS STRIPPED, IT IS FELT BY THE END-USER THAT THIS WAS THE CAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMEX ROLLATOR ROLLATOR IOR DAN YANG JU MAO HEALTHCARE EQUIPMENT CO., LTD. RJ4600R NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other