BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLX 300 XENON LIGHTSOURCE W/AUSTRALIAN POWER

    MDR report key: 2719381 · Received August 28, 2012

    Report

    Report Number
    1222895-2012-00024
    Event Type
    Malfunction
    Date Received
    August 28, 2012
    Date of Event
    July 30, 2012
    Report Date
    August 28, 2012
    Manufacturer
    INTEGRA BURLINGTON, MA INC.
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    INITIAL REPORT INDICATED PT WAS BURNED ON BREAST DURING BREAST SURGERY. IT APPEARS THAT A RETRACTOR HAD HEATED UP AND MAY HAVE CAUSED THIS BURN. CLINICAL CARE PROVIDED FOR THE BURN - NO FURTHER INFO ABOUT PT IS AVAILABLE. ON (B)(6) 2012 DEALER E-MAIL REPORT RELAYS INFO FROM NURSING UNIT MGR AT THE (B)(6). LEFT BREAST AUGMENTATION, NO INFO FOR DEGREE OR SIZE OF BURN, TREATMENT COMFELL DRESSING. BREAST RETRACTOR IS A SNOWDEN-PENCER TEBBETTS FIBER OPTIC CODE - 88-1088.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MLX 300 XENON LIGHTSOURCE W/AUSTRALIAN POWER NA GCT INTEGRA BURLINGTON, MA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 FIBEROPTIC CABLE NOT YET IDENTIFIED BY CUSTOMER| BREAST RETRACTOR - SNOWDEN-PENCER TEBBETTS| FIBER OPTIC CODE 88-1088