BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 3687558 · Received March 12, 2014

    Report

    Report Number
    1222895-2014-00004
    Event Type
    Injury
    Date Received
    March 12, 2014
    Date of Event
    December 5, 2013
    Report Date
    February 28, 2014
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    FCW
    PMA / PMN Number
    K081477
    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 EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    A CAREFUSION REP INITIALLY REPORTS TO INTEGRA THAT A PT SUSTAINED A BURN INJURY FROM THE CONNECTION SITE BETWEEN THE RETRACTOR (CAREFUSION DEVICE) AND THE LIGHT CORD. THE LIGHT SOURCE, LUXTER, MLX BY INTEGRA HAS BEEN REMOVED FROM SERVICE. THE NUMBERS FOR THE TEBBETS RETRACTOR ARE 88-1087, 88-1088 ND 88-1090. THE PRODUCTS (RETRACTORS) WERE VISUALLY INSPECTED PRIOR TO SURGERY. ON (B)(6) 2013, THE NURSE MANAGER REPORTED VIA TELEPHONE THAT ONE PT WAS BURNED. THE BURN LOCATION IS UNK. SHE STATED THAT THE BURN OCCURRED FROM THE CONNECTION SITE. IT IS UNK WHICH OF THE RETRACTORS CAUSED THE BURN. ALL THREE WERE USED DURING THE CASE. THE INCIDENT OCCURRED ON (B)(6) 2013 DURING REMOVAL OF BILATERAL BREAST TISSUE EXPANDERS AND PLACEMENT OF PERMANENT SILICONE IMPLANTS. THE BURN WOUND WAS DRESSED. THE PROCEDURE WAS NOT DELAYED. THE PT HAS SINCE BEEN DISCHARGED. ON (B)(6) 2014, NURSE MANAGER-PLASTIC SURGERY REPORTS A SNOWDEN PENSER 5MM CABLE (PRODUCT NUMBER 889727) WAS USED AND A 3.5MM CABLE SHOULD HAVE BEEN USED. SHE DOES NOT BELIEVE THE MLX LIGHT SOURCE WAS THE REASON FOR THE PT BURN. BIOMEDICAL PROFESSIONAL REPORTS HE FOUND NOTHING WRONG WITH OPERATION OF THE MLX. HE BELIEVES, IT IS OPERATING ACCORDING TO SPECS, (B)(6) 2014 DEALER FORWARDED COPY OF HOSPITAL MDR TO INTEGRA. IT REPORTS AN APPROX 4 CM BURN DEVELOPED INTERIOR TO THE RIGHT BREAST, APPEARING LIGHT PINK IN COLOR DEALER FORWARDED COPY OF HOSPITAL MDR TO INTEGRA. IT REPORTS AN APPROX 4 CM BURN DEVELOPED INFERIOR TO THE RIGHT BREAST, APPEARING LIGHT PINK IN COLOR OINTMENT AND A WOUND DRESSING WERE APPLIED TO THE AREA AFTER THE PROCEDURE. DURING A F/U CLINIC APPOINTMENT, ANOTHER WOUND DRESSING WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149188 MLX 300W XENON LIGHTSOURCE NA FCW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR