BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELFOAM (ABSORBABLE GELATIN) MEDICATED SPONGE

    MDR report key: 2796867 · Received October 15, 2012

    Report

    Report Number
    1810189-2012-00003
    Event Type
    Other
    Date Received
    October 15, 2012
    Report Date
    October 3, 2012
    Manufacturer
    PFIZER, INC.
    Product Code
    LMF
    PMA / PMN Number
    18-286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CASE COMMENT: BASED ON THE INFORMATION PROVIDED IN THIS REPORT, AND A TEMPORAL ASSOCIATION, A POSSIBLE CONTRIBUTORY ROLE OF GELFOAM TO THE EVENT ANAPHYLACTIC REACTION CANNOT BE COMPLETELY EXCLUDED. GELFOAM SHOULD BE USED WITH CAUTION IN A POTENTIALLY CLOSED SPACE. THE EVENT ANAPHYLACTIC REACTION PRESENTING AS WIDE SPREAD ERYTHEMATOUS RASH AND POSSIBLY HYPOTENSION AND VENTILATOR DIFFICULTY MOST LIKELY REPRESENTS AN INTRAOPERATIVE ANAPHYLAXIS TO GELATIN IN TOPICAL HEMOSTATIC AGENTS [ABSORBABLE GELATIN (GELFOAM) SPONGE AND GELATIN/THROMBIN (FLOSEAL HEMOSTATIC MATRIX)] USED IN ANTERIOR SPINAL FUSION IN THIS PATIENT. HYPOTENSION AND VENTILATOR DIFFICULTY IN THIS CASE COULD ALSO BE ATTRIBUTED TO THE BLEEDING DURING SURGERY AS NOTED IN THIS REPORT. 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.

    Description of Event or Problem · 1

    INTRAOPERATIVE ANAPHYLAXIS [ANAPHYLACTIC REACTION]. CASE DESCRIPTION: THIS IS A LITERATURE SPONTANEOUS REPORT FROM THE ABSTRACT OF THE SPINE JOURNAL 12, 2012, ENTITLED "INTRAOPERATIVE ANAPHYLAXIS TO GELATIN IN TOPICAL HEMOSTATIC AGENTS DURING ANTERIOR SPINAL FUSION: A CASE REPORT," BASED ON INFORMATION RECEIVED BY PFIZER FROM BAXTER ((B)(4)). THE FULL PUBLICATION HAS BEEN REQUESTED. A (B)(6) MALE RECEIVED ABSORBABLE GELATIN (GELFOAM) SPONGES FOR PREPARATION OF THE DISC SPACES DURING ANTERIOR SPINAL FUSION FROM T12 TO L3. THE PATIENT MEDICAL HISTORY INCLUDED MYELOMENINGOCELE AND SCOLIOSIS. CONCOMITANT MEDICATIONS WERE UNKNOWN. APPROXIMATELY 1 HOUR AFTER THE APPLICATION OF ABSORBABLE GELATIN, ABSORBABLE GELATIN/THROMBIN (FLOSEAL HEMOSTATIC MATRIX) WAS APPLIED TO A BRISKLY BLEEDING SCREW HOLE IN THE L3 VERTEBRAL BODY. THE PATIENT EXPERIENCED AN ABRUPT ONSET OF HYPOTENSION AND VENTILATOR DIFFICULTY. EPINEPHRINE, DEXAMETHASONE, AND BLOOD PRODUCTS WERE ADMINISTERED FOR HEMODYNAMIC SUPPORT WHILE THE SURGICAL SITE WAS CLOSED. REMOVAL OF THE DRAPES REVEALED A WIDE SPREAD ERYTHEMATOUS RASH, AND THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT. THREE DAYS LATER, WHEN THE PATIENT WAS STABLE, HE RETURNED TO THE OPERATING ROOM FOR COMPLETION OF THE SPINAL FUSION. POSTOPERATIVE LABORATORY ASSAYS REVEALED ELEVATED LEVELS OF TRYPTASE, TOTAL IGE, PORCINE, AND BOVINE GELATIN SPECIFIC IGE. THE PATIENT WAS COUNSELED TO AVOID GELATIN CONTAINING PRODUCTS. AT THE 6 MONTH FOLLOW UP, HIS INSTRUMENTED SPINE WAS RADIOGRAPHICALLY FUSED AND HE REPORTED NO FURTHER ALLERGIC ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELFOAM (ABSORBABLE GELATIN) MEDICATED SPONGE SPONGE, STERILE; CLASS III LMF PFIZER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other| R