BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN & SHURTLEFF

    MDR report key: 360010 · Received November 9, 2001

    Report

    Report Number
    MW1023367
    Event Type
    Injury
    Date Received
    November 9, 2001
    Date of Event
    October 17, 2001
    Report Date
    October 23, 2001
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    FTF
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRANSILLUMINATOR USED ON A PREMATURE INFANT TO VISUALIZE VEINS FOR IV INSERTION. WAND OF THE TRANSILLUMINATOR NOT IN PLACE WHILE BEING USED. CAUSING BLISTER FORMATION ON INFANT'S RIGHT HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50104 CODMAN & SHURTLEFF TRANSILLUMINATOR FTF CODMAN & SHURTLEFF 243032 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY Required Intervention