BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOSCOPE II NEONATAL TRANSILLUMINATOR

    MDR report key: 747263 · Received November 10, 2005

    Report

    Report Number
    MW1037150
    Event Type
    Injury
    Date Received
    November 10, 2005
    Date of Event
    November 2, 2005
    Report Date
    November 10, 2005
    Manufacturer
    VENOSCOPE, LLC
    Product Code
    HJN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report

    Narratives

    Description of Event or Problem · 1

    PT NEEDED IV STARTED. VENOSCOPE II NEONATAL TRANSILLUMINATOR USED TO AID SITE SLECTION. TRANSILLUMINATOR OFF FOR MOST OF THE TIME DURING SITE SELECTION. NURSE CHECKED TEMPERATURE OF LIGHT ON TRANSILLUMINATOR SEVERAL TIMES; LIGHT NOT HOT. HOWEVER, LIGHT WAS HELD IN PLACE FOR 2 MINUTES DURING PROCEDURE. AFTER TASK COMPLETED, AN OPEN AND SLIGHTLY WEEPING AREA NOTED IN FOREARM WITH SCANT FLUID AND MILD EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 VENOSCOPE II NEONATAL TRANSILLUMINATOR NEONATAL TRANSILLUMINATOR HJN VENOSCOPE, LLC KT01 *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Required Intervention