BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT GUIDE, A 225F3.5-NA SNOWD

    MDR report key: 3466373 · Received November 4, 2013

    Report

    Report Number
    1222895-2013-00027
    Event Type
    Injury
    Date Received
    November 4, 2013
    Report Date
    November 4, 2013
    Manufacturer
    INTEGRA BURLINGTON, MA, INC
    Product Code
    EQH
    PMA / PMN Number
    K864387
    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 ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE DEALER REPORTS THAT THIS COMPLAINT WAS OPENED TO CAPTURE THE REPORTED INCIDENT WITH THE SECOND PATIENT THAT WAS BURNED. NOTE: MEDWATCH FOR PATIENT #1 WAS FILED UNDER 1222895-2013-00026. THE PATIENT SUFFERED A SMALL 1ST DEGREE BURN DURING A BREAST RECONSTRUCTION REQUIRING BACITRACIN OINTMENT. THE CASE WAS NOT DELAYED AND WAS COMPLETED WITHIN THIS SURGEONS TIME GUIDELINES. 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. BOTH INCIDENTS INVOLVED THE SAME SURGEON. THE SAME CABLE WAS USED IN BOTH INSTANCES. ON (B)(4) 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)(4) 2013 DEALER TRYING TO GET LIGHT SOURCE INFORMATION FROM USER. PATIENT #2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566362 LIGHT GUIDE, A 225F3.5-NA SNOWD NA EQH INTEGRA BURLINGTON, MA, INC F215W

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR