BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM SURGICAL FIBER OPTIC RETRACTOR

    MDR report key: 5681349 · Received May 26, 2016

    Report

    Report Number
    5681349
    Event Type
    Malfunction
    Date Received
    May 26, 2016
    Date of Event
    January 7, 2016
    Report Date
    May 13, 2016
    Manufacturer
    ELMED INC
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT WOUND CLOSURE A BURN (BLISTER-2ND DEGREE) ON PATIENT'S UPPER LATERAL RIGHT CHEST, SIZE 3 X 1.5 CM WAS NOTICED. BURN WAS CAUSED BY THE USE OF A LIGHTED FIBER OPTIC BREAST RETRACTOR. WOUND WAS DRESSED WITH BACITRACIN OINTMENT, TELFA DRESSING AND TEGADERM PER MD ORDER. THE CONNECTION BETWEEN THE FIBER CABLE AND THE RETRACTOR GETS VERY HOT WHEN THE LIGHT IS ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337212 MILLENNIUM SURGICAL FIBER OPTIC RETRACTOR RETRACTOR GAD ELMED INC E0316

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other FIBER OPTIC LIGHT SOURCE AND LIGHT CABLE