BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUNOPTIC TECHNOLOGIES

    MDR report key: 1913083 · Received August 10, 2010

    Report

    Report Number
    1035968-2010-00002
    Event Type
    Other
    Date Received
    August 10, 2010
    Date of Event
    June 23, 2010
    Report Date
    July 29, 2010
    Manufacturer
    SUNOPTIC TECHNOLOGIES C/O SERVICE AND TECH SUPPORT
    Product Code
    FSS
    PMA / PMN Number
    K961074
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PICTURE OR DETAILED DESCRIPTION OF THE ACTUAL BURN IT IS IMPOSSIBLE TO DETERMINE HOW THIS COULD HAVE OCCURRED. THE LIGHT SPOT FROM THE HEADLIGHT IS CIRCULAR AND IT WAS NOTED THAT THE BURN WAS "CRESANT SHAPED" WHICH CAUSES ONE TO WONDER HOW THE BURN COULD BE FROM THE HEADLIGHT. CERTAINLY ON A BREAST ONE MIGHT EXPECT THE SURFACE TISSUE TO BE SUCH THAT AN AREA RAPIDLY RECEDES FROM THE SOURCE OF THE LIGHT THUS REDUCING ITS INTENSITY. NONETHELESS, IT SEEMS MORE LIKELY THE BURN WOULD BE GENERALLY CIRCULAR. WITHOUT FURTHER INFORMATION THIS CANNOT BE PROPERLY ADDRESSED. ALL EQUIPMENT (TWO EACH LIGHTHOUSES, HEADLIGHTS AND FIBEROPTIC CABLES) WERE RETURNED TO US AND WERE EVALUATED BY OUR SERVICE AND REPAIR TECHNICIAN AS WELL AS AN ENGINEER. ALL EQUIPMENT WAS FOUND TO BE IN EXCELLENT WORKING CONDITION WITH NO ABNORMALITIES PRESENT.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR STAGE II RIGHT BREAST RECONSTRUCTION WITH REMOVAL OF TISSUE EXPANDERS AND PLACEMENT OF SILICONE GEL IMPLANTS WITH LEFT BREAST REDUCTION FOR SYMMETRY PURPOSES. IT WAS NOTED DURING THE PROCEDURE THAT THE PATIENT HAD SUSTAINED A CRESCENT SHAPED FIRST DEGREE BURN ON THE SKIN AT THE RIGHT BREAST INCISION SITE. NO BLISTERS WERE SEEN. THE AREA WAS BANDAGED ALONG WITH THE ROUTINE BREAST DRESSINGS. IT WAS THOUGHT THAT THE HEADLIGHT THAT THE SURGEON WAS WEARING AND USING MAY HAVE CAUSED THE BURN BY HEATING THE TISSUE EXCESSIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNOPTIC TECHNOLOGIES HEADLIGHT FSS SUNOPTIC TECHNOLOGIES C/O SERVICE AND TECH SUPPORT UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other