BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENON LIGHT SOURCE 300 WATT

    MDR report key: 1403547 · Received May 29, 2009

    Report

    Report Number
    1221336-2009-00002
    Event Type
    Malfunction
    Date Received
    May 29, 2009
    Date of Event
    March 23, 2009
    Report Date
    May 28, 2009
    Manufacturer
    INTEGRA LUXTEC, INC.
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    CUSTOMER MEDWATCH FORM REPORT REPORTS THAT "A LIGHTED HARRINGTON WAS USED AND TOUCHED THE PATIENT'S RIGHT BREAST AND CAUSED A BURN. IT WAS DETERMINED BY THE CUSTOMER THAT IT WAS WHERE THE LIGHT SOURCE CONNECTED INTO THE LIGHT CORD THAT BURNED THE PATIENT." ADDITIONAL INFORMATION FROM THE CLAIMS ATTORNEY REPORTS THAT THE TWO PRODUCTS USED WITH THE LUX TEC LIGHT SOURCE WERE A HARRINGTON LIGHTED RETRACTOR, PRODUCT NUMBER 08-0052 MANUFACTURED BY (B) (4); AND A LIGHT CABLE, PRODUCT NUMBER 459ND MANUFACTURED BY (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENON LIGHT SOURCE 300 WATT FTD INTEGRA LUXTEC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR