BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHOTODYNAMIC THERAPY

    MDR report key: 351238 · Received September 7, 2001

    Report

    Report Number
    MW4003084
    Event Type
    Death
    Date Received
    September 7, 2001
    Date of Event
    September 26, 1997
    Manufacturer
    *
    Product Code
    GEX
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A PROCEDURE KNOWN AS PHOTODYNAMIC THERAPY FOR THE TREATMENT OF SKIN LESIONS ON CHEST, NECK, AND FACE SECONDARY TO BREAST CANCER. AT THE TIME OF THIS TREATMENT, PHOTODYNAMIC THERAPY WAS ONLY FDA APPROVED FOR THE TREATMENT OF ESOPHAGEAL CANCER. THE TREATMENT WAS COMPLETED UNDER THE DIRECTION OF DR. AS A RESULT OF THIS TREATMENT, PT SUFFERED FULL THICKNESS SKIN LOSS REQUIRING TWICE DAILY DRESSING CHANGES THAT CONTINUED UNTIL THEIR DEATH. RPTR IS ASKING THAT FDA REVIEW THIS CASE BASED ON THE FOLLOWING CONCERNS: 1. INADEQUATE INFORMED CONSENT. PRIOR TO THE PROCEDURE, THE ONLY RISKS MADE KNOWN TO PT WERE THE POSSIBILITY OF A MILD SUNBURN, MILD SWELLING, AND THE POSSIBILITY OF A BLISTER. ALTHOUGH PT WAS NEVER PROVIDED A COPY OF THE INFORMED CONSENT, THE CONSENT DOES NOT DISCUSS THE RISKS OF WOUNDS, EVEN THOUGH ON PAGES 17-18 OF THE DEPOSITION, DR STATES "ALL PTS REQUIRE WOUND THERAPY". ADD'L DISCUSSION REGARDING WHO WAS RESPONSIBLE FOR OBTAINING AN INFORMED CONSENT. OF GREAT CONCERN IS THE SEVERITY OF INJURY INFLICTED BY THIS TREATMENT ON A TERMINALLY ILL PT. THAT THIS WAS AN "ANTICIPATED OUTCOME" IS CLEARLY NOTED ON DR'S OFFICE NOTE. UNFORTUNATELY, WHILE THIS WAS AN ANTICIPATED OUTCOME FOR DR, PT WAS NEVER INFORMED OF THIS FACT. 2. DEFINITION OF HUMAN EXPERIMENTATION: THERE IS A SIGNIFICANT LACK OF CLARITY REGARDING DR'S DEFINITION OF HUMAN EXPERIMENTATION AND UNDER WHAT RULES AND/OR REGULATIONS HE TREATED PT. DR STATES THIS PROCEDURE WAS AN "OFF-LABEL USE OF AN APPROVED COMPOUND." DR REFERS TO THE USE OF "POOLED DATA", "WE HAD NO FORMAL STUDY INITIATED" ALTHOUGH A PROTOCOL DID EXIST, AND HE STATES "ALL OF OUR PTS ARE PART OF INFORMAL STUDIES." 3. POTENIAL CONFLICT OF INTEREST: DR INDICATED THAT ON THE DATE OF PT'S TREATMENT, HE WAS A COMPENSATED LECTURER IN A PHOTODYNAMIC THERAPY TRAINING PROGRAM. COMPENSATION WAS PROVIDED BY SANOFI PHARMACEUTICAL CORP. IN ADDITION, REPS OF VARIOUS LASER DEVICES (AND THEIR DEVICES) WERE PRESENT AT THE CONFERENCE. THE DEVICE USED ON PT WAS SPECIFICALLY SHIPPED IN FOR THE CONFERENCE. 4. LACK OF CLARITY OVER WHO OPERATED THE DEVICE: WHEN ASKED WHO OPERATED THE EQUIPMENT, ANSWERS ARE AMBIGUOUS. IT IS UNCLEAR WHETHER THE LASER CO REP WAS INVOLVED. PT, REALIZING THAT THEY HAD NOT BEEN ADEQUATELY INFORMED OF THE COMPLICATIONS ASSOCIATED WITH THIS PROCEDURE, CONTACTED AN ATTORNEY PRIOR TO THEIR DEATH AND A CASE WAS FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40749 PHOTODYNAMIC THERAPY PHOTODYNAMIC THERAPY GEX * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death