BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMITEXMD LIGHT MAT

    MDR report key: 1571434 · Received December 31, 2009

    Report

    Report Number
    MW5014230
    Event Type
    Other
    Date Received
    December 31, 2009
    Date of Event
    December 22, 2009
    Report Date
    December 31, 2009
    Manufacturer
    LUMITEX
    Product Code
    HJN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT CYSTOCELE REPAIR WITH MESH. WHEN DRAPES WERE TAKEN OFF OF THE PATIENT, A QUARTER SIZED SECOND-DEGREE SKIN BURN WAS NOTED AT THE 4:00 POSITION, THE PATIENT'S LEFT ABDOMEN, LATERAL TO THE UMBILICUS. SURGEON INJECTED 10ML OF 0.25 BUPIVACAINE, APPLIED SILVADENE AND COVERED IT WITH A TEGADERM. PLASTIC SURGEON LATER CONTACTED FOR A CONSULT AND WOUND MANAGEMENT. THOUGHT TO HAVE BEEN FROM THE MALE/FEMALE ATTACHMENTS. PRODUCT INSTRUCTIONS IN THE CORE INDICATE THAT ACMI LIGHT CORD CAN BE USED WITH THE LUMITEX LIGHT MAT - THE ITEM THAT BURNED THE PATIENT-. HOWEVER, ACCORDING TO THE VP OF SALES WITH LUMITEX, THEY ONLY RECOMMEND USING THEIR SPECIALLY DESIGNED LIGHT CORDS WHICH HAVE A HEAT DEFLECTING ELEMENT IN THE PORTION OF THE LIGHT CORD WHICH BURNED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMITEXMD LIGHT MAT LIGHT MAT HJN LUMITEX
    2 ACMI CORD CORD HJN LUMITEX

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other