BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENON LIGHT SOURCE 300 WATT W/

    MDR report key: 3035047 · Received March 6, 2013

    Report

    Report Number
    1222895-2013-00009
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    March 9, 2013
    Manufacturer
    INTEGRA BURLINGTON MA, INC.
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS VIA MEDWATCH #(B)(4). PT'S LEFT ANTERIOR NECK WAS BURNED WITH MEDIASTINAL SCOPELIGHT SOURCE. THIS WAS NOTICED BY HOUSE OFFICER AT END OF CASE. THIS WAS BROUGHT TO THE ATTENTION OF MD WHO SUGGESTED APPLYING BACITRACIN OINTMENT TO THE SITE. BURN WAS APPROXIMATELY A DIME SIZED WHITE AREA. FLEXIBLE BRONCHOSCOPY, MEDIASTINOSCOPY, LEFT UPPER LOBECTOMY, AND MEDIASTINAL LYMPH NODE DISSECTION WAS BEING PERFORMED. ON (B)(6) 2013, CUSTOMER IS NOT RESPONDING TO REPEATED TELEPHONE CONVERSATIONS, AT LEAST THREE REQUESTS FOR SPECIFIC ANSWERS TO QUESTIONS/INFORMATION NEEDED REGARDING OTHER EQUIPMENT USED WITH LIGHTSOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96421 XENON LIGHT SOURCE 300 WATT W/ NA FCW INTEGRA BURLINGTON MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR