BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELFOAM SPONGE

    MDR report key: 1244469 · Received November 26, 2008

    Report

    Report Number
    1810189-2008-00005
    Event Type
    Injury
    Date Received
    November 26, 2008
    Date of Event
    November 1, 2008
    Report Date
    November 19, 2008
    Manufacturer
    PFIZER
    Product Code
    LMF
    PMA / PMN Number
    18-286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT REGARDING A MEDICAL DEVICE FROM A PHARMACIST WHO REPORTS ON A PATIENT USING ABSORBABLE GELATIN SPONGE (GELFOAM). A PATIENT OF UNKNOWN AGE AND GENDER UNDERWENT A BRAIN OPERATION IN THE BEGINNING OF 2008 AND ABSORBABLE GELATIN SPONGE WAS USED DURING THE OPERATION. A SURGEON TOUCHED THE OUTSIDE OF THE PAPER BACK OF ABSORBABLE GELATIN SPONGE, (INSIDE THE ALUMINUM PACKAGE). IT WAS NOT STERILIZED AND SURGERY WAS PERFORMED WHICH RESULTED IN INFECTIOUS MENINGITIS. AS OF 2008, THE PATIENT'S FEVER WAS MARKEDLY IMPROVED, BUT THE EVENT REMAINED. IT WAS POINTED OUT THAT THE DESCRIPTIONS ABOUT THE STERILIZED PACKAGING OF ABSORBABLE GELATIN SPONGE WERE DIFFICULT TO UNDERSTAND. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. THE NEED FOR CORRECTIVE ACTION IS BEING EVALUATED AND WILL BE COMMUNICATED IN A FOLLOW-UP REPORT. COMPANY CLINICAL EVALUATION: A REVIEW OF PFIZER'S SAFETY DATABASE FOR CASES RECEIVED THROUGH 2008 IDENTIFIED 0 SERIOUS CASES FROM SOLICITED CASES AND CLINICAL STUDIES REPORTING ABSORBABLE GELFOAM SPONGE OR BLINDED THERAPY AND ADVERSE EVENTS ENCODING TO THE MEDDRA (VERSION 11.1.) PREFERRED TERM MENINGITIS FURTHER REPORTING A VERBATIM OR LOWER LEVEL TERM OF INFECTIOUS MENINGITIS. THREE SERIOUS CASES FROM SOLICITED CASES AND CLINICAL STUDIES REPORTING ABSORBABLE GELFOAM SPONGE OR BLINDED THERAPY AND ADVERSE EVENTS ENCODING TO THE MEDDRA (VERSION 11.1) PREFERRED TERM MENINGITIS WERE IDENTIFIED. A REVIEW OF THESE THREE CASES FOUND NO LANGUAGE TO INDICATE THE TRANSMISSION OF INFECTION BY SURGICAL MATERIALS. ABSORBABLE GELATIN SPONGE (GELFOAM) IS A STERILE DEVICE AND IF STERILE TECHNIQUES WERE MAINTAINED IN PREPARATION FOR BRAIN SURGERY AS WELL AS DURING BRAIN SURGERY IN THE OPERATING ROOM, THERE IS NO REASONABLE POSSIBILITY THAT THE EVENT "INFECTIOUS MENINGITIS" OR THE "SUSPECTED TRANSMISSION OF AN INFECTIOUS AGENT" IS ATTRIBUTABLE TO GELFOAM. BASED ON THE INFORMATION PROVIDED IN THE CASE, THIS INDIVIDUAL REPORT WOULD NOT SEEM TO MODIFY THE RISK-BENEFIT PROFILE OF THE SUBJECT DEVICE. ROOT CAUSE ANALYSIS FOR THE DEVICE IS UNDER INVESTIGATION AND WILL BE PROVIDED ONCE IT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELFOAM SPONGE SPONGE, STERILE LMF PFIZER

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O