BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMINAL FIBER OPTIC LIGHT

    MDR report key: 76949 · Received January 21, 1997

    Report

    Report Number
    76949
    Event Type
    Other
    Date Received
    January 21, 1997
    Date of Event
    November 5, 1996
    Report Date
    November 12, 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

    PT HAD A ROUND REDDENED AREA ON LEFT ANKLE AFTER USING THE TRANSILLUMINATOR TO START IV. PT WAS DISCHARGED. NO FURTHER TREATMENT NECESSARY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 DAY Other