BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTMAT

    MDR report key: 1709655 · Received May 19, 2010

    Report

    Report Number
    1709655
    Event Type
    Malfunction
    Date Received
    May 19, 2010
    Date of Event
    May 18, 2010
    Report Date
    May 19, 2010
    Manufacturer
    LUMITEX, INC.
    Product Code
    HJN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    NOTED BURN ON LEFT UPPER ARM OF PATIENT DURING BREAST SURGERY-THREE 10 MM BLISTERS. IT IS THOUGHT TO BE DUE TO THE CONNECTION BETWEEN THE END OF THE DISPOSABLE LIGHTMAT AND THE GRAY NON-DISPOSABLE LIGHT CORD WHICH IS ATTACHED TO THE XENON LIGHT BOX. THIS CONNECTION BECAME VERY HOT. APPARENTLY THE CONNECTION BETWEEN THE DISPOSABLE LIGHTED RETRACTOR AND THE NONDISPOSABLE CORD GETS REALLY HOT. ====================== HEALTH PROFESSIONAL'S IMPRESSION======================APPARENTLY THE CONNECTION BETWEEN THE DISPOSABLE LIGHTED RETRACTOR AND THE NONDISPOSABLE CORD GETS REALLY HOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTMAT SURGICAL ILLUMINATOR HJN LUMITEX, INC. * L01369

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR NO OTHER THERAPIES