BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APLIGRAF

    MDR report key: 3010347 · Received March 14, 2013

    Report

    Report Number
    1221816-2013-00001
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    January 1, 2012
    Report Date
    February 13, 2013
    Manufacturer
    ORGANOGENESIS, INC.
    Product Code
    MGR
    PMA / PMN Number
    P950012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    APLIGRAF LOT # GS1211.13.04.1A (UNIT # UNCONFIRMED FROM CUSTOMER) WAS PACKAGED ON (B)(6) 2012 AND TRANSFERRED TO SHIPPING ON (B)(4) 2012. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT INDICATED THE LOT MET ALL SPECIFICATIONS AND RELEASE CRITERIA FOR SHIPMENT. THERE WAS ONE OTHER COMPLAINT ASSOCIATED WITH THE SAME LOT, BUT IT WAS INITIATED FOR A WOUND INFECTION THAT OCCURRED WITH THE SAME PATIENT DURING THE SAME TIME FRAME UNDER COMPLAINT # (B)(4). THE AVAILABLE INFORMATION FOR THIS MEDICAL EVENT WAS REVIEWED BY DR (B)(6), ORGANOGENESIS INC ON (B)(6) 2013 AND ASSESSED AS NOT RELATED TO APLIGRAF.

    Description of Event or Problem · 1

    ORGANOGENESIS, INC. WAS NOTIFIED OF THE EVENT ON (B)(6)2013 VIA MEDICAL INQUIRY RECEIVED. EVENT DESCRIPTION: ON (B)(6) 2013, ORGANOGENESIS INC (OI), WAS NOTIFIED BY THE DIRECTOR OF THE (B)(6) AT (B)(6), REGARDING A PATIENT WHO PRESENTED WITH AN ULCER ON THE ANTERIOR ASPECT OF HIS LOWER LEG (WHETHER RIGHT (R) OR (L) LEG NOT REPORTED/UNKNOWN). ON AN UNKNOWN DATE, SQUAMOUS CELL CARCINOMA (SCC) WAS REPORTED VIA WOUND BIOPSY REPORT RESULTS. PER THE (B)(6) STAFF, THE PATIENT WAS INITIALLY VERY EXCITED ABOUT THE APLIGRAF AND WAS VERY INTERESTED IN THE GROWTH FACTORS AND OTHER THINGS THAT IF RELEASED. BUT, "WITH THE POSSIBLE DIAGNOSIS OF SCC, HE (THE PATIENT) IMMEDIATELY MADE THE CONNECTION THAT PUTTING GROWTH FACTORS ON A CARCINOMA WOULD NOT BE A GOOD THING." DR (B)(6) FOLLOWED UP WITH / CONTACTED BOTH THE INITIAL REPORTER AND THE PATIENT REGARDING THE SCC EVENT, THEIR INQUIRES AND EXPRESSED CONCERNS. ADDITIONAL INFORMATION WAS OBTAINED FROM (B)(6) AND THE PATIENT, A (B)(6) MALE, REGARDING THE ACTUAL DIAGNOSIS, HISTORY OF THE PRESENTING CONDITION, CO-MORBIDITIES, CONCOMITANT MEDICATIONS AND THE REPORTED EVENT OUTCOME. THE PATIENT, A (B)(6) MALE (INITIALS AND DATE OF BIRTH UNKNOWN), HAD A MEDICAL HISTORY INCLUDING HISTORY OF SQUAMOUS CELL CARCINOMA PRIOR TO APLIGRAF TREATMENT (NO ADDITIONAL DETAILS WERE PROVIDED). INFORMATION REGARDING ADDITIONAL CO-MORBIDITIES, CONCOMITANT MEDICATIONS AND ALLERGY HISTORY WAS NOT REPORTED/IS UNKNOWN. THIS (B)(6) MALE PATIENT (INITIALS AND DATE OF BIRTH UNKNOWN), HAD BEEN TREATED FOR APPROXIMATELY SIX MONTHS AT (B)(6) FOR AN ULCER ON THE ANTERIOR ASPECT OF HIS LOWER LEG THAT HAD REPORTEDLY BEEN OPEN "FOR THIRTY YEARS" (WHETHER ULCER WAS ON R OR L LEG WAS NOT REPORTED/ UNKNOWN). IT WAS REPORTED THAT BECAUSE THE PATIENT HAD SOME VENOUS COMPONENTS TO HIS WOUND, (B)(6) BEGAN TREATMENT WITH DEBRIDEMENTS AND COMPRESSION, TO WHICH THE PATIENT WAS RESPONDING. BECAUSE HE WAS RESPONDING, THIS FURTHERED THE BELIEF THAT THE PATIENT'S VENOUS SYSTEM WAS INVOLVED (SUBSEQUENTLY, THE LEG WOUND'S ETIOLOGY WAS NOT CONSIDERED TO BE DUE TO VENOUS INSUFFICIENCY). ALTHOUGH PROGRESSING, THE WOUND WAS NOT HEALING VERY FAST OR WITH SIGNIFICANT CHANGE. THEREFORE, A COURSE OF APLIGRAF WAS BEGUN ON (B)(6) 2012. THE PATIENT HAD FOUR APLIGRAF APPLICATIONS. DUE TO THE PATIENT'S WOUND BEING LESS THAN 44 CM2 (LENGTH, WIDTH AND DEPTH MEASUREMENTS NOT PROVIDED), ONE UNIT WAS APPLIED WITH EACH APLIGRAF APPLICATION. DURING THE WEEK FOLLOWING THE (B)(6) 2012 APLIGRAF APPLICATION, THERE HAD BEEN A BREAK IN THE PATIENT'S WEEKLY THERAPY DUE TO AN INFECTION (ONSET DATE UNKNOWN; A WOUND CULTURE WAS COLLECTED, RESULTS NOT PROVIDED) FOR WHICH THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. FOLLOWING RECEIPT OF A WOUND CULTURE RESULT INDICATING "NO MORE INFECTION," THE PATIENT'S APLIGRAF APPLICATIONS RESUMED. THE INFECTION WAS ASSESSED AS NOT RELATED TO APLIGRAF, ((B)(4)). AFTER 4 WEEKS, THE REPORTER INDICATED THE WOUND DID NOT PROGRESS AS "WE WERE HOPING FOR" THEREFORE A WOUND BIOPSY WAS PERFORMED. INTERESTING TO NOTE WAS THAT, PER (B)(6) STAFF, THE PATIENT, A RETIRED CHIROPRACTOR, FREQUENTLY DEBRIDED HIS WOUND WITH SHARP INSTRUMENTS AND USED COTTON SWABS TO "CLEAN" THE WOUND. WOUND BED PREPARATION REPORTEDLY CONSISTED OF "DEBRIDEMENTS AND COMPRESSION" TO WHICH THE PATIENT "WAS RESPONDING." NO INFORMATION REGARDING APLIGRAF APPEARANCE, PREPARATION, WOUND DRESSINGS OR ADJUNCT THERAPIES WAS REPORTED. THE PATIENT HAD FOUR APLIGRAF APPLICATIONS, ONE UNIT EACH APPLICATION, ON (B)(6) 2012 (CONFLICTING INFORMATION RECEIVED). WITH THE EXCEPTION OF LOT # GS1211.13.04.1A BEING UTILIZED FOR THE (B)(6) 2012 APPLICATION, LOT NUMBERS AND UNIT NUMBERS WERE NOT REPORTED. ON AN UNKNOWN DATE, BECAUSE THE PATIENT'S WOUND HAD NOT PROGRESSED "AS HOPED FOR," A WOUND BIOPSY WAS PERFORMED. THE RESULTS CAME BACK AS SQUAMOUS CARCINOMA. THE REPORTED SQUAMOUS CELL CARCINOMA HAS YET TO BE CONFIRMED. SKIN BIOPSIES AND HISTOPATHOLOGY PERFORMED AT TWO INSTITUTIONS ((B)(6)) WERE INCONCLUSIVE. (B)(6) REPORTED THAT THE BIOPSY MAY BE CONSISTENT WITH SQUAMOUS CELL CARCINOMA HOWEVER, THE PATHOLOGIST WAS UNABLE TO MAKE A DEFINITIVE DETERMINATION. THE (B)(6) PATHOLOGY REPORT DEMONSTRATED GENERAL INFLAMMATORY CELLS WITH PROLIFERATION OF FIBROBLASTS AND KERATINOCYTES, BUT CONCLUDED NO EVIDENCE OF SCC WAS FOUND. AS NOTED ABOVE, THE PATIENT REPORTED HE HAD A HISTORY OF SCC PRIOR TO APLIGRAF APPLICATION (NO OTHER DETAILS WERE PROVIDED). NO ADDITIONAL INFORMATION REGARDING THE SCC EVENT WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE SCC HAS BEEN ASSESSED AS NOT RELATED TO APLIGRAF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108547 APLIGRAF NONE MGR ORGANOGENESIS, INC. GS1211.13.04.1A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other NONE PROVIDED.