BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT GUIDE, A225F3.5-NA SNOWD

    MDR report key: 3452480 · Received October 30, 2013

    Report

    Report Number
    1222895-2013-00026
    Event Type
    Injury
    Date Received
    October 30, 2013
    Report Date
    October 30, 2013
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    FCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    DEALER REPORTS THE PATIENT WAS BURNED AT THE CONNECTOR SITE FOR HE CORD AND THE LIGHTED BREAST RETRACTOR. IT WAS INITIALLY REPORTED THAT ONE CORD WAS INVOLVED IN TWO DIFFERENT CASES. THE PATIENT SUFFERED A SMALL 2ND DEGREE BURN DURING A BREAST AUGMENTATION REQUIRING TREATMENT OF COLD SALINE, SILVADENE CREAM, AND TELFA. NEITHER CASE WAS DELAYED AND BOTH CASES WERE COMPLETED WITHIN THIS SURGEONS TIME GUIDELINE IN BOTH INSTANCES, THE EQUIPMENT WAS FOUND TO BE INTACT AND FUNCTIONAL AT THE TIME OF SURGERY. NO OTHER DEVICES OR INSTRUMENTATION WERE REQUIRED AS A RESULT OF THIS. THESE RETRACTORS AND LIGHT CORD HAVE NOT BEEN REPAIRED OR REQUIRED ANY THIRD PARTY REFURBISHING. A SECOND PATIENT WAS ALSO BURNED WITH THE FIBER-OPTIC LIGHT CABLE. BOTH INCIDENTS INVOLVED THE SAME SURGEON. THE SAME CABLE WAS USED IN BOTH INSTANCES. ON (B)(6) 2013, DEALER REPORTS ONE OF THE FOLLOWING THREE RETRACTORS WAS USED, DOESN'T KNOW WHICH - TEBBETTS BREAST RETRACTORS. PRODUCT #: 88-1088, SERIAL #: (B)(4); PRODUCT #: 88-1087, SERIAL #: (B)(4); PRODUCT #: 88-1086, SERIAL #: (B)(4). ON (B)(6) 2013 DEALER TRYING TO GET LIGHT SOURCE INFORMATION FROM USER. PATIENT #1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556797 LIGHT GUIDE, A225F3.5-NA SNOWD NA FCW INTEGRA BURLINGTON, MA, INC. F215W

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR