BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIED FIBEROPTICS

    MDR report key: 421814 · Received October 10, 2002

    Report

    Report Number
    MW1026404
    Event Type
    Injury
    Date Received
    October 10, 2002
    Date of Event
    September 6, 2002
    Manufacturer
    APPLIED FIBEROPTICS INC.
    Product Code
    FCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TRANSILLUMINATOR WAS USED TO VISUALIZE VEINS FOR AN IV STICK. MD'S + NNP AWARE OF SITE TO RT WRIST WITH 2 DARKENED AREAS. SITE PROGRESSIVELY DARKENED OVER NEXT FEW HRS AND BEGAN SLOUGHING. THIS WAS WHERE THE TRANSILLUMINATOR WAS PLACED. DR CONSULTED AND ORDER WAS PLACED FOR QD HYDRAGRAM DRESSINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APPLIED FIBEROPTICS MICRO SYSTEM TWIN-BEAM LIGHTSOURCE FCW APPLIED FIBEROPTICS INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Required Intervention