BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMINA 1 FIBER OPTIC LIGHT

    MDR report key: 76947 · Received January 21, 1997

    Report

    Report Number
    76947
    Event Type
    Other
    Date Received
    January 21, 1997
    Date of Event
    November 3, 1996
    Report Date
    November 8, 1996
    Manufacturer
    CHIU TECHNICAL CORP.
    Product Code
    LEK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRANSILLUMINATOR WAS USED TO VISUALIZE VEINS TO START IV. SMALL BLISTERS WERE NOTED ON THE PT'S RIGHT ANKLE, RIGHT PALM, AND RIGHT WRIST AFTER THE USE OF THE DEVICE. BLISTERS ARE HEALING WITH NO FURTHER MEDICAL INTERVENTION. NEW FIBER OPTIC CABLE WAS PLACED ON THE DEVICE 10/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMINA 1 FIBER OPTIC LIGHT TRANSILLUMINATOR LEK CHIU TECHNICAL CORP. BFO - 150 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DAY Other