BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELFOAM PLUS (ABSORBABLE GELATIN, THROMBIN) DEVICE

    MDR report key: 3592784 · Received November 15, 2013

    Report

    Report Number
    2937398-2013-00001
    Event Type
    Other
    Date Received
    November 15, 2013
    Report Date
    November 6, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE LITERATURE DESCRIPTION: JOURNAL: ANN ALLERGY ASTHMA IMMUNOL. AUTHOR: KHORIATY, E. TITLE: INTRAOPERATIVE ANAPHYLAXIS INDUCED BY THE GELATIN COMPONENT OF THROMBIN-SOAKED GELFOAM IN A PEDIATRIC PATIENT. VOLUME: 108 YEAR: 2012 PAGES: 206-213.

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS IS A LITERATURE REPORT FROM ANN ALLERGY ASTHMA IMMUNOL, 2012, 108; 206-213, ENTITLED "INTRAOPERATIVE ANAPHYLAXIS INDUCED BY THE GELATIN COMPONENT OF THROMBIN-SOAKED GELFOAM IN A PEDIATRIC PATIENT." A 2 1/2-YEAR-OLD GIRL WITH A HISTORY OF TETRALOGY OF FALLOT STATUS POST REPAIR UNDERWENT TETHERED SPINAL CORD REPAIR IN A LATEX-FREE ENVIRONMENT. SHE WAS ORALLY PREMEDICATED WITH MIDAZOLAM AND KETAMINE AND RECEIVED INTRAOPERATIVE FENTANYL, SEVOFLURANE, ETOMIDATE, DEXAMETHASONE, CEFAZOLIN, AND A CRYSTALLOID INFUSION (LACTATED RINGERS). TWO AND A HALF HOURS LATER, THROMBIN-SOAKED ABSORBABLE GELATIN (GELFOAM PLUS) WAS APPLIED ON THE DURAMATER, AND HER WOUND WAS IRRIGATED WITH 50,000 UNITS OF BACITRACIN SOLUTION. WITHIN 2 TO 3 MINUTES, SHE DEVELOPED GENERALIZED URTICARIA, A DROP IN HER SYSTOLIC BLOOD PRESSURE FROM 110 TO 50 MMHG, AND A DECREASE OF HER OXYGEN SATURATION FROM 99% TO 90% WITH MARKED DIFFICULTY IN VENTILATION. SHE RESPONDED QUICKLY TO IMMEDIATE HIGH-PRESSURE MANUAL VENTILATION, ALBUTEROL, DIPHENHYDRAMINE, INTRAVENOUS FLUIDS, AND EPHEDRINE, WHICH WAS READILY AVAILABLE FOR INSTANT USE. AFTER THE ALLERGY SERVICE WAS CONSULTED, IT WAS REVEALED POSTOPERATIVELY THAT A FEW MONTHS PRIOR THE PATIENT DEVELOPED GENERALIZED HIVES, LIP SWELLING, AND ABDOMINAL PAIN 20 MINUTES AFTER INGESTING SPAM, WHICH IS CANNED PORK MEAT WITH A CHARACTERISTIC GELATINOUS GLAZE, ALSO KNOWN AS ASPIC. HER CONDITION REQUIRED EPINEPHRINE ADMINISTRATION IN AN OUTSIDE EMERGENCY ROOM. SHE HAD SINCE TOLERATED PORK, MILK, EGG, WHEAT, SEAFOOD, PEANUT, AND TREENUTS AND HAD NOT EATEN SOY. ABSORBABLE GELATIN IS AN ABSORBABLE GELATIN SPONGE INTENDED FOR APPLICATION TO BLEEDING SURFACES AS A HEMOSTATIC AGENT AND PREPARED FROM PURIFIED PORK SKIN GELATIN. IT CAN BE USED ALONE OR IN COMBINATION WITH TOPICAL THROMBIN. FOR THIS PATIENT, GIVEN THAT THE THROMBIN-SOAKED ABSORBABLE GELATIN AND SPAM HAVE PORCINE GELATIN AS A COMMON INGREDIENT, IT WAS HIGHLY SUSPECTED THAT THE ANTIGEN INDUCING THESE 2 ANAPHYLACTIC REACTIONS WAS GELATIN. PATIENT UNDER SKIN-PRICK TESTING WAS PERFORMED ON THE BACK TO HISTAMINE (HOLLISTER-STIER, SPOKANE, WASHINGTON; 6 MG/ML HISTAMINE BASE, 10 MG/ML HISTAMINE DIHYDROCHLORIDE), PRESERVATIVE- FREE PORCINE GELATIN (COLLEGE PHARMACY, COLORADO SPRINGS, COLORADO), FULL-STRENGTH BACITRACIN SOLUTION (1,000 UNITS/ML), MMR-II (MERCK PHARMACEUTICALS, FULL-STRENGTH SOLUTION, CONTAINING 14.5 MG OF HYDROLYZED PORCINE GELATIN PER DOSE), SOY (GREER LABORATORIES, LENOIR, NORTH CAROLINA), AND NORMAL SALINE (0.9%). SHE WAS POSITIVE TO GELATIN (WHEAL 15, FLARE 40) AND HISTAMINE (WHEAL 7, FLARE 30) AND NEGATIVE TO NORMAL SALINE, BACITRACIN, MMR-II, AND SOY. SPECIFIC IMMUNOGLOBULIN E WAS POSITIVE TO PORCINE GELATIN (1.81 KU/L) AND NEGATIVE TO BOVINE GELATIN (ARUP LABORATORIES, SALT LAKE CITY, UTAH). GIVEN HER CARDIAC CONDITION, INTRADERMAL TESTING FOR MMR II WAS PERFORMED AND WAS POSITIVE AT 1:10 DILUTION. (WHEAL 9, FLARE 15, WITH A NONREACTIVE INTRADERMAL NORMAL SALINE). THIS CONCENTRATION WAS FOUND TO BE NONIRRITANT IN 20 HEALTHY VOLUNTEERS. THE PATIENT RECEIVED UNEVENTFULLY MMR-II VACCINE USING A STEPWISE PROTOCOL INVOLVING 6 INCREMENTAL DOSES GIVEN SUBCUTANEOUSLY WITH A 20-MINUTE INTERVAL BETWEEN EACH DOSE (0.05 ML 1:100 DILUTION, 0.05 ML 1:10 DILUTION, 0.05 ML FULL-STRENGTH, 0.1 ML FULL-STRENGTH, 0.15 ML FULL STRENGTH, 0.2 ML FULL-STRENGTH). THIS PROTOCOL IS SIMILAR TO THE ALGORITHM RECOMMENDED BY WOOD ET AL3 FOR PATIENTS WITH IMMEDIATE HYPERSENSITIVITY REACTIONS TO VACCINES OR THEIR COMPONENTS. ALTHOUGH OUR PATIENT MAY HAVE BEEN DESENSITIZED MMR-II, IT IS ALSO POSSIBLE THAT SHE HAS TOLERATED THE SMALL AMOUNT OF HYDROLYZED GELATIN PRESENT IN THE VACCINE. SHE HAS SINCE TOLERATED MIDAZOLAM, FENTANYL, SEVOFLURANE, KETAMINE, CEFAZOLIN, AND LACTATED RINGERS. WE REPORT THE FIRST CASE OF ANAPHYLAXIS FROM THROMBIN-SOAKED ABSORBABLE GELATIN APPLICATION, WHICH WAS SECONDARY TO PORCINE GELATIN HYPERSENSITIVITY. IN ADDITION, IT IS ALSO THE FIRST REPORT DESCRIBING ANAPHYLAXIS TO ASPIC. WE RECOMMEND INQUIRING ABOUT GELATIN ALLERGY NOT ONLY IN DRUGS BUT ALSO IN FOOD AS PART OF THE PREOPERATIVE ASSESSMENT WHEN THE USE OF GELATIN-CONTAINING PRODUCTS IS ANTICIPATED. IF SUSPECTED, AN ALLERGY SERVICE CONSULTATION WOULD BE WARRANTED BEFORE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. CASE COMMENT: BASED ON THE INFORMATION PROVIDED IN THIS REPORT, THIS PEDIATRIC PATIENT WITH A RELEVANT MEDICAL HISTORY OF TETRALOGY OF FALLOT STATUS POST REPAIR UNDERWENT TETHERED SPINAL CORD REPAIR IN A LATEX-FREE ENVIRONMENT. AS NOTED IN THIS REPORT TWO AND A HALF HOURS LATER, THROMBIN-SOAKED ABSORBABLE GELATIN (GELFOAM PLUS) WAS APPLIED ON THE DURA, AND HER WOUND WAS IRRIGATED WITH 50,000 UNITS OF BACITRACIN SOLUTION. WITHIN 2 TO 3 MINUTES, SHE DEVELOPED GENERALIZED URTICARIA, A DROP IN HER SYSTOLIC BLOOD PRESSURE FROM 110 TO 50 MMHG, AND A DECREASE OF HER OXYGEN SATURATION FROM 99% TO 90% WITH MARKED DIFFICULTY IN VENTILATION. SHE RESPONDED QUICKLY TO IMMEDIATE HIGH-PRESSURE MANUAL VENTILATION, ALBUTEROL, DIPHENHYDRAMINE, INTRAVENOUS FLUIDS, AND EPHEDRINE, WHICH WAS READILY AVAILABLE FOR INSTANT USE. ON CONSULTATION WITH THE ALLERGY SERVICE IT WAS REVEALED POSTOPERATIVELY THAT A FEW MONTHS PRIOR, THIS PATIENT DEVELOPED GENERALIZED HIVES, LIP SWELLING, AND ABDOMINAL PAIN 20 MINUTES AFTER INGESTING SPAM (ASPIC). ABSORBABLE GELATIN IS AN ABSORBABLE GELATIN SPONGE INTENDED FOR APPLICATION TO BLEEDING SURFACES AS A HEMOSTATIC AGENT AND PREPARED FROM PURIFIED PORK SKIN GELATIN. IT CAN BE USED ALONE OR IN COMBINATION WITH TOPICAL THROMBIN. FOR THIS PATIENT, GIVEN THAT THE THROMBIN-SOAKED ABSORBABLE GELATIN AND SPAM HAVE PORCINE GELATIN AS A COMMON INGREDIENT, IT WAS HIGHLY SUSPECTED THAT THE ANTIGEN INDUCING THESE 2 ANAPHYLACTIC REACTIONS WAS GELATIN. HENCE A POSSIBLE CONTRIBUTORY ROLE OF GELFOAM TO THE REPORTED EVENTS CANNOT BE COMPLETELY EXCLUDED DUE TO THE TEMPORAL ASSOCIATION. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE. CASE COMMENT: BASED ON THE INFORMATION PROVIDED IN THIS REPORT, THIS PEDIATRIC PATIENT WITH A RELEVANT MEDICAL HISTORY OF TETRALOGY OF FALLOT STATUS POST REPAIR UNDERWENT TETHERED SPINAL CORD REPAIR IN A LATEX-FREE ENVIRONMENT. AS NOTED IN THIS REPORT TWO AND A HALF HOURS LATER, THROMBIN-SOAKED ABSORBABLE GELATIN (GELFOAM PLUS) WAS APPLIED ON THE DURAMATER, AND HER WOUND WAS IRRIGATED WITH 50,000 UNITS OF BACITRACIN SOLUTION. WITHIN 2 TO 3 MINUTES, SHE DEVELOPED GENERALIZED URTICARIA, A DROP IN HER SYSTOLIC BLOOD PRESSURE FROM 110 TO 50 MMHG, AND A DECREASE OF HER OXYGEN SATURATION FROM 99% TO 90% WITH MARKED DIFFICULTY IN VENTILATION. SHE RESPONDED QUICKLY TO IMMEDIATE HIGH-PRESSURE MANUAL VENTILATION, ALBUTEROL, DIPHENHYDRAMINE, INTRAVENOUS FLUIDS, AND EPHEDRINE, WHICH WAS READILY AVAILABLE FOR INSTANT USE. ON CONSULTATION WITH THE ALLERGY SERVICE IT WAS REVEALED POSTOPERATIVELY THAT A FEW MONTHS PRIOR, THIS PATIENT DEVELOPED GENERALIZED HIVES, LIP SWELLING, AND ABDOMINAL PAIN 20 MINUTES AFTER INGESTING SPAM (ASPIC). ABSORBABLE GELATIN IS AN ABSORBABLE GELATIN SPONGE INTENDED FOR APPLICATION TO BLEEDING SURFACES AS A HEMOSTATIC AGENT AND PREPARED FROM PURIFIED PORK SKIN GELATIN. IT CAN BE USED ALONE OR IN COMBINATION WITH TOPICAL THROMBIN. FOR THIS PATIENT, GIVEN THAT THE THROMBIN-SOAKED ABSORBABLE GELATIN AND SPAM HAVE PORCINE GELATIN AS A COMMON INGREDIENT, IT WAS HIGHLY SUSPECTED THAT THE ANTIGEN INDUCING THESE 2 ANAPHYLACTIC REACTIONS WAS GELATIN. HENCE A POSSIBLE CONTRIBUTORY ROLE OF GELFOAM TO THE REPORTED EVENTS CANNOT BE COMPLETELY EXCLUDED DUE TO THE TEMPORAL ASSOCIATION. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592575 GELFOAM PLUS (ABSORBABLE GELATIN, THROMBIN) DEVICE KIT; CLASS III LMF BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other| R