BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMEX ROLLATOR

    MDR report key: 833970 · Received March 28, 2007

    Report

    Report Number
    MW1042437
    Event Type
    Other
    Date Received
    March 28, 2007
    Date of Event
    February 6, 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 02/06/07, THE END-USER'S WIFE CALLED IN, VIA TELEPHONE, REPORTING THAT THE LEFT FRONT WHEEL STEM BOLT STARTED BENDING 2 MONTHS PRIOR TO THE INCIDENT. END-USER DID NOT SEEK MEDICAL ATTENTION OR SUSTAINED INJURIES.

    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 M060406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other