BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXENON

    MDR report key: 3554163 · Received December 31, 2013

    Report

    Report Number
    MW5033694
    Event Type
    Injury
    Date Received
    December 31, 2013
    Date of Event
    November 16, 2009
    Report Date
    December 30, 2013
    Manufacturer
    BFW
    Product Code
    FTD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT LUMBOSACRAL LAMINECTOMIES FOR DERMAL SINUS TRACT AND TETHERED CORD. SURGICAL TIME WAS 2 HOURS AND 21 MINUTES. FOLLOWING THE SURGERY, AS IOBAN DRAPES WERE REMOVED, A PARTIAL THICKNESS OF THE SKIN ADHERED TO THE DRAPES ON THE RIGHT SIDE, APPROX 3.5 BY 6 CM. WOUND MANAGEMENT AND PLASTIC SURGERY WERE CONSULTED. PLASTIC SURGERY NOTED AN AREA OF PARTIALLY DE-EPITHELIALIZED AREA WITH THE APPEARANCE OF A BURN. THE AREA WAS TENDER WITH NO PURULENCE OR ERYTHEMA. PLASTIC SURGERY RECOMMENDED B.I.D. XEROFORM DRESSING CHANGES AS WELL AS BACITRACIN. THE PT WAS DISCHARGED TO HOME POST-OP DAY 7. TWO MOTHS POST-OP THE WOUND WAS EVALUATED BY PLASTIC SURGERY AND FOUND TO BE FULLY EPITHELIALIZED. INITIALLY THE INJURY WAS THOUGHT TO BE RELATED TO REMOVAL OF THE SURGICAL DRAPES. SUBSEQUENT INVESTIGATION EVALUATED POTENTIAL CAUSES OF THE INJURY, INCLUDING DRAPES, PREP SOLUTIONS, TECHNIQUES, ETS AND DETERMINED THE INJURY WAS MOST LIKELY A BURN RELATED TO HEAT FROM THE BFW MAXENON XI300 LIGHT SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682503 MAXENON MAXENON XI300 XENON LIGHT SOURCE FTD BFW XI300

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Other IOBAN DRAPES| DRAPREP| ALCHOL| CHLORHEXIDINE SCRUB SPONGE PRESCRUB| DETADINE SCRUB