BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR

    MDR report key: 5141754 · Received October 8, 2015

    Report

    Report Number
    1226354-2015-00001
    Event Type
    Injury
    Date Received
    October 8, 2015
    Date of Event
    September 7, 2013
    Report Date
    September 8, 2015
    Manufacturer
    DUSA PHARMACEUTICALS, INC.
    Product Code
    MVF
    PMA / PMN Number
    P990019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2015 INFORMATION WAS RECEIVED FROM A (B)(6) MALE PATIENT WHO RECEIVED TREATMENT FOR ACTINIC KERATOSES ON (B)(6), 2013 WITH LEVULAN KERASTICK AND BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR CONSISTING OF APPLICATION OF THE LEVULAN KERASTICK TO THE ENTIRE FACE, FOLLOWED BY EXPOSURE TO BLU-U LIGHT. THE PATIENT REPORTED WEARING GOGGLES DURING LIGHT EXPOSURE AND DENIES ANY LEVULAN DRIPPED INTO HIS EYES. HE ALSO DENIES ANY PAIN, STINGING OR DISCOMFORT IN THE EYES. ON (B)(6), 2013, THE PATIENT REPORTED HE AWOKE WITH A SLIGHT AMOUNT OF VISION LOSS IN HIS LEFT EYE. HE WENT TO HIS OPHTHALMOLOGIST WHO BELIEVES THE VISION LOSS MAY HAVE BEEN CAUSED BY A SLIGHT STROKE INVOLVING THE OPTIC NERVES. ON (B)(6), 2013, THE PATIENT REPORTED BEING COMPLETELY BLIND IN THE LEFT EYE. HE WAS EXAMINED BY A SECOND OPHTHALMOLOGIST ON (B)(6), 2013, AND INTRAOCULAR FLUID FROM THE LEFT EYE WAS TAKEN AND TESTED POSITIVE FOR SHINGLES VIRUS STRAIN, WHICH MAY HAVE BEEN IN ITS DORMANT STATE. THE PATIENT REPORTED THE OPHTHALMOLOGIST FELT THAT THE SHOCK OF THE PDT TREATMENT PROBABLY AGITATED THE DORMANT SINGLES VIRUS, MAKING IT ATTACK THE OPTIC NERVE CAUSING BLINDNESS. AS OF (B)(6), 2015 THE PATIENT REPORTED THE EVENT F TOTAL BLINDNESS IN THE LEFT EYE IS ON-GOING. ACCORDING THE COMPANY'S CHIEF MEDICAL OFFICER, THE REPORTED EVENT OF UNILATERAL BLINDNESS OCCURRING 11 DAYS POST PDT IN THE ABSENCE OF PAIN, SWELLING, INFLAMMATION OR SPILLAGE OF LEVULAN DESPITE THE FINDING OF HERPES VIRUS IN INTRAOCULAR FLUID, THE COURSE OF THIS SPECIFIC CASE IS FAR MORE TYPICAL OF OPTIC NEURITIS THAN OF A REACTIVATED HERPES VIRUS INFECTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: ON (B)(6) 2013 A MALE PATIENT RECEIVED HIS SECOND TREATMENT FOR ACTINIC KERATOSES (AKS) WITH LEVULAN KERASTICK AND BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR CONSISTING OF A SKIN PREPARATION OF TWO (2) PASSES WITH ACETONE WIPES TO DEGREASE THE SKIN, FOLLOWED BY APPLICATION OF LEVULAN TO THE ENTIRE FACE, INCUBATION FOR 1 HOUR. PATIENT WAS PROVIDED WITH, AND PUT ON APPROPRIATE GOGGLES PRIOR TO PLACEMENT UNDER THE BLU-U LIGHT, AND WAS EXPOSED TO LIGHT SOURCE FOR 16 MINUTES 40 SECONDS. OF NOTE, THE PATIENT WAS TREATED PROPHYLACTICALLY WITH ACYCLOVIR 800MG ONE DAY PRIOR TO AND THE DAY OF PDT TREATMENT. THE TREATMENT WAS WELL TOLERATED. POST PROCEDURE TITANIUM AND ZINC SUNSCREEN WAS APPLIED TO THE PATIENTS FACE AND INSTRUCTIONS FOR SUN AVOIDANCE WERE GIVEN, AS WELL AS INFORMATION FOR PATIENT TO CALL SHOULD HE EXPERIENCE EXCESSIVE PAIN, SWELLING, COLD SORES ETC. THE OPHTHALMOLOGIST REPORTED: RR EXPERIENCED LEFT ACUTE RETINAL NECROSIS (ARN) FOLLOWING PDT TREATMENT, "HE DOES NOT KNOW IF THE TREATMENT WAS THE CAUSE OF THE ZOSTER IN THE PATIENTS EYE, MANY PATIENTS GET OCULAR ZOSTER, AND THE CAUSE IS NOT KNOWN, BUT THE VIRUS (ZOSTER) IS THE CAUSE OF THE BLINDNESS". NO FURTHER INFORMATION IS EXPECTED. ACCORDING TO THE COMPANY'S CHIEF MEDICAL OFFICER, THE NEW INFORMATION RECEIVED DOES NOT CHANGE THE MEDICAL ASSESSMENT OF THE EVENT WHICH WAS UNLIKELY TO BE RELATED TO LEVULAN PDT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669573 BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR BLU-U MVF DUSA PHARMACEUTICALS, INC. 4170-1D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other| S