BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE INFINITY TRANSILLUMINATOR

    MDR report key: 358788 · Received October 30, 2001

    Report

    Report Number
    358788
    Event Type
    Injury
    Date Received
    October 30, 2001
    Date of Event
    October 15, 2001
    Report Date
    October 30, 2001
    Manufacturer
    FIBEROPTIC MEDICAL PRODUCTS, INC
    Product Code
    MQW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFANT SUFFERED TWO, SECOND-DEGREE BURNS FOLLOWING TRANSILLUMINATION TO FACILITATE PUNCTURE OF THE LEFT ULNAR WRIST ARTERY. THE INFRARED BLOCKING FILTER WAS FOUND TO BE DISLODGED, RESULTING IN INCREASED LIGHT INTENSITY AND INCREASED TEMPERATURE TO THE SKIN SURFACE OF THE BACK OF THE WRISTS. THE INJURY CONSISTED OF TWO, SECOND-DEGREE BURNS OF 1/2CM EACH TO THE ANTERIOR SIDE OF THE WRISTS. EACH SECOND-DEGREE BURN RESULTED IN A RAISED, FLUID-FILLED VESICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48647 THE INFINITY TRANSILLUMINATOR PORTABLE HIGH-POWERED FIBEROPTIC EXAMINATION LIGHT MQW FIBEROPTIC MEDICAL PRODUCTS, INC IT-101 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3.5 MO Other| R