BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOTODYNAMIC THERAPY

    MDR report key: 6739854 · Received July 24, 2017

    Report

    Report Number
    MW5071186
    Event Type
    Injury
    Date Received
    July 24, 2017
    Date of Event
    June 6, 2017
    Report Date
    June 16, 2017
    Manufacturer
    DUSA PHARMACEUTICALS, INC.
    Product Code
    MVF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I WAS RECOMMENDED BY FACULTY AT (B)(6) TO UNDERGO "PHOTODYNAMIC THERAPY" FOR TREATMENT OF ACTINIC KERATOSIS ON BOTH HANDS AND ARM. I HAD THE PROCEDURE AT UIC ON (B)(6) BOTH ARMS WERE TREATED WITH KERASTICK (LEVULAN), LEFT HAND/ARM EXPOSED TO BLUE LIGHT, RIGHT HAND/ARM EXPOSED TO RED LIGHT. BY EVENING, I EXPERIENCED EXTREME ITCHING, AND BY MORNING OF (B)(6), I HAD EXTREME REDNESS ON BOTH ARMS AND HANDS. BY AFTERNOON OF (B)(6), I DEVELOPED SEVERE BLISTERING, SWELLING, PAIN AND BURNING IN BOTH LIMBS. UIC PRESCRIBED TRIAMCINOLONE AND HYDROXYZINE, AND I HAD TO CONSULT OUTSIDE PHYSICIANS FOR OPINIONS. I SPOKE WITH DR. (B)(6) OF (B)(6), WHO MANUFACTURE THE DRUG KERASTICK, AND HE ADVISED ME THAT KERASTICK IS ONLY FDA APPROVED FOR USE ON SCALP AND FACE; THE FDA APPLICATION FOR USE OF KERASTICK ON LIMBS AND EXTREMITIES HAS ONLY RECENTLY BEEN MADE, SO THE UIC PHYSICIANS SEEM TO HAVE BEEN CONDUCTING AN UNAUTHORIZED CLINICAL EXPERIMENT WITHOUT MY KNOWLEDGE OR PERMISSION. DR. (B)(6) SAID THAT MY REACTION WAS UNUSUAL IN ITS SEVERITY. ADDENDUM BY (B)(6) ON (B)(6) 2017 2:37 PM (VERIFIED). SPOKE WITH PT'S HUSBAND, TODAY AND HE STATED THAT THE PT WAS CLOSE BY THE PHONE, IMPROVING AND BLISTERING HAS BEEN RESOLVED. BLISTERS HAVE DRIED OUT AND THE SKIN IS BECOMING READY TO PEEL. HUSBAND HAS ASKED IF ANY PERMANENT SKIN PIGMENT CHANGES WOULD FOLLOW THIS RESPONSE. I HAVE EXPLAINED THAT WE DO NOT GET ANY PERMANENT PIGMENT CHANGES DUE TO PDT AND HAVE STRONGLY ADVICE DAILY SPF OVER 30, MOISTURIZATION, AVOIDANCE OF PICKING DRY SKIN. AGGRESSIVE MOISTURIZATION DUE TO EXTENSIVE REACTION. MANY CONT TAC AND HYDROXYZINE AS NEEDED PER ITCHING SYMPTOMS. HUSBAND AND PT STATE THAT ARE VERY KNOWLEDGEABLE AS FAR AS WOUND CARE. HAVE OFFERED TO SEE THE PT TO CLINIC A F/U ANYTIME BUT HUSBAND AND PT STATE THAT ARE UNABLE TO COME DUE TO LONG DISTANCE WHICH IS UNDERSTOOD. STRONGLY ENCOURAGED TO RTC/CALL BACK WITH ANY ADD'L QUESTIONS OR CONCERNS. EXTENSIVE EDUCATION REGARDING THE ABOVE ENTITY. HUSBAND - AND PT EXPRESSED FULL UNDERSTANDING. ALL PT'S QUESTIONS WERE ANSWERED TODAY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 08/03/2017 FOR MW5071186: THIS LETTER CONTAINS UPDATES SINCE MY LAST CORRESPONDENCE, AND I WISH THIS INFORMATION TO BE ADDED TO MY MEDWATCH FILE. ON (B)(6)2017, MY HUSBAND (B)(6) AND I MET WITH MS. (B)(4), DIRECTOR OF PATIENT SAFETY AND RISK MANAGEMENT FOR (B)(6), AND DR. (B)(6), CHIEF MEDICAL OFFICER FOR THE (B)(6). THE PURPOSE OF THE MEETING WAS TO DISCUSS MY EXPERIENCES IN PHOTODYNAMIC THERAPY (PDT) TREATMENT WITH DR. (B)(6) AT (B)(6), DISCUSS MY INJURIES FROM PDT, AND DETERMINE HOW THIS MAY HAVE HAPPENED. I TOLD THE (B)(6) REPRESENTATIVES THAT I HAD FELT "GROOMED" FOR THE PDT TREATMENT AND ENCOURAGED THAT PDT "WAS THE BEST WAY TO GO FORWARD," WITHOUT EVER HAVING BEEN INFORMED THAT THE PROCEDURE WAS NOT FDA APPROVED FOR EXTREMITIES. I TOLD THEM THAT WE WERE NEVER GIVEN ANY PRINTED MATTER OR INSTRUCTION SHEETS SAVE FOR ONE HANDWRITTEN NOTE IN MY HUSBAND'S NOTEBOOK BY DR. (B)(6) RESIDENT. FURTHERMORE, I TOLD THEM THAT THE TREATMENT OF BLUE LIGHT FOR LEFT ARM AND RED LIGHT FOR RIGHT ARM FELT VERY EXPERIMENTAL, AS IF DATA WERE BEING COLLECTED. MS. (B)(4) SAID THAT THE (B)(6) IRB INSISTS THAT DR. (B)(6) IS NOT PERFORMING RESEARCH ON PDT AT (B)(6), DESPITE WEBSITE MENTIONS AND HER AWARD FROM THE (B)(4) IN 2011, "CUTTING EDGE" GRANT. MS. (B)(4) SAID THAT THE REASON DR. (B)(6) USED BLUE LIGHT ON MY LEFT ARM AND RED LIGHT ON MY RIGHT ARM WAS BECAUSE "THE RIGHT ARM HAD MORE ACTINIC KERATOSIS (AK) DAMAGE THAN THE LEFT ARM." I QUESTION THIS, AS DR. (B)(6) ONLY EXAMINED ME FOR A FEW MINUTES BEFORE APPLYING THE KERASTICK DRUG TO BOTH ARMS, AND THERE HAS NEVER BEEN ANY MENTION OF DIFFERENCE OF AK DAMAGE TO MY ARMS DURING YEARS OF TREATMENT BY (B)(6) DERMATOLOGY, INCLUDING BY DR. (B)(6), WHO REFERRED ME TO DR. (B)(6). MY HUSBAND, WHO HAS EXTENSIVE EDUCATION AND TRAINING IN EPIDEMIOLOGY AND BIOSTATISTICS, MENTIONED ONE OF DR. (B)(6)' RESEARCH PAPERS, "PREDICTIVE DOSIMETRY FOR THRESHOLD PHOTOTOXICITY IN PHOTODYNAMIC THERAPY ON NORMAL SKIN: RED WAVELENGTHS PRODUCE MORE EXTENSIVE DAMAGE THAN BLUE AT EQUAL THRESHOLD DOSES," (JOURNAL OF INVESTIGATIVE DERMATOLOGY, VOLUME 108, ISSUE 4, APRIL 1997, PAGES 501-505) TO DEMONSTRATE THAT DR. (B)(6) WOULD HAVE KNOWN THAT TREATING MY RIGHT HAND AND ARM WITH HIGH-POWERED RED LIGHT WOULD CAUSE DAMAGE. MS. (B)(4) SAYS THAT DR. (B)(6) DISMISSED THIS PAPER AS BEING BASED UPON ANIMAL RESEARCH MODELS INSTEAD OF HUMANS. I AM ATTACHING A DETAILED NARRATIVE OF THE EVENTS OF THE PDT TREATMENT AND PHOTOGRAPHS OF THE DAMAGE TO BOTH HANDS TO SUPPLEMENT MY ONLINE REPORTING. PLEASE ADD THESE MATERIALS TO MY COMPLAINT FILE, AND THANK YOU FOR FILING THE COMPLAINT AGAINST DR. (B)(6) WITH THE (B)(4) DEPARTMENT OF PROFESSIONAL REGULATION ON MY BEHALF. BY THE EVENING OF (B)(6), (B)(6) WAS UNABLE TO SLEEP DUE TO EXCESSIVE ITCHING AND BURNING. AT 4:30 AM, SHE AWAKENED (B)(6) AND COMPLAINED ABOUT THE PAIN AND ITCHING. (B)(6) SUGGESTED THAT (B)(6) TAKE ONE OF (B)(6)'S ANTI-ITCH ANTIHISTAMINES (HYDROXYZINE 25 MG) AND USE TOPICAL ANTIHISTAMINE LOTION.

    Description of Event or Problem · 1

    I WAS RECOMMENDED BY FACULTY AT (B)(6) TO UNDERGO "PHOTODYNAMIC THERAPY" FOR TREATMENT OF ACTINIC KERATOSIS ON BOTH HANDS AND ARM. I HAD THE PROCEDURE AT UIC ON (B)(6) BOTH ARMS WERE TREATED WITH KERASTICK (LEVULAN), LEFT HAND/ARM EXPOSED TO BLUE LIGHT, RIGHT HAND/ARM EXPOSED TO RED LIGHT. BY EVENING, I EXPERIENCED EXTREME ITCHING, AND BY MORNING OF (B)(6), I HAD EXTREME REDNESS ON BOTH ARMS AND HANDS. BY AFTERNOON OF (B)(6), I DEVELOPED SEVERE BLISTERING, SWELLING, PAIN AND BURNING IN BOTH LIMBS. UIC PRESCRIBED TRIAMCINOLONE AND HYDROXYZINE, AND I HAD TO CONSULT OUTSIDE PHYSICIANS FOR OPINIONS. I SPOKE WITH DR. (B)(6) OF (B)(6), WHO MANUFACTURE THE DRUG KERASTICK, AND HE ADVISED ME THAT KERASTICK IS ONLY FDA APPROVED FOR USE ON SCALP AND FACE; THE FDA APPLICATION FOR USE OF KERASTICK ON LIMBS AND EXTREMITIES HAS ONLY RECENTLY BEEN MADE, SO THE UIC PHYSICIANS SEEM TO HAVE BEEN CONDUCTING AN UNAUTHORIZED CLINICAL EXPERIMENT WITHOUT MY KNOWLEDGE OR PERMISSION. DR. (B)(6) SAID THAT MY REACTION WAS UNUSUAL IN ITS SEVERITY. ADDENDUM BY (B)(6) ON (B)(6) 2017 2:37 PM (VERIFIED). SPOKE WITH PT'S HUSBAND, TODAY AND HE STATED THAT THE PT WAS CLOSE BY THE PHONE, IMPROVING AND BLISTERING HAS BEEN RESOLVED. BLISTERS HAVE DRIED OUT AND THE SKIN IS BECOMING READY TO PEEL. HUSBAND HAS ASKED IF ANY PERMANENT SKIN PIGMENT CHANGES WOULD FOLLOW THIS RESPONSE. I HAVE EXPLAINED THAT WE DO NOT GET ANY PERMANENT PIGMENT CHANGES DUE TO PDT AND HAVE STRONGLY ADVICE DAILY SPF OVER 30, MOISTURIZATION, AVOIDANCE OF PICKING DRY SKIN. AGGRESSIVE MOISTURIZATION DUE TO EXTENSIVE REACTION. MANY CONT TAC AND HYDROXYZINE AS NEEDED PER ITCHING SYMPTOMS. HUSBAND AND PT STATE THAT ARE VERY KNOWLEDGEABLE AS FAR AS WOUND CARE. HAVE OFFERED TO SEE THE PT TO CLINIC A F/U ANYTIME BUT HUSBAND AND PT STATE THAT ARE UNABLE TO COME DUE TO LONG DISTANCE WHICH IS UNDERSTOOD. STRONGLY ENCOURAGED TO RTC/CALL BACK WITH ANY ADD'L QUESTIONS OR CONCERNS. EXTENSIVE EDUCATION REGARDING THE ABOVE ENTITY. HUSBAND - AND PT EXPRESSED FULL UNDERSTANDING. ALL PT'S QUESTIONS WERE ANSWERED TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518353 PHOTODYNAMIC THERAPY SYSTEM, LASER, PHOTODYNAMIC THERAPY MVF DUSA PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    0 Disability
    1 57 YR Disability