BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHISORB DURA PATCH

    MDR report key: 5903983 · Received August 25, 2016

    Report

    Report Number
    1226348-2016-10604
    Event Type
    Injury
    Date Received
    August 25, 2016
    Date of Event
    January 13, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GXQ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PART NUMBER, UDI UNAVAILABLE. THIS FILE AND ARTICLE WAS DISCUSSED AT LENGTH WITH THE CHU MANAGEMENT, CLINICIAN AND MEDICAL SAFETY OFFICER. THE PHYSIOLOGIC FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT AND THE PATIENT SYMPTOMS WERE REVIEWED. THE IFU WAS DISCUSSED. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER FOR THE SUBJECT DEVICE WAS NOT REPORTED. AT THIS TIME THIS COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    IN THE LITERATURE SEARCH "UNABSORBED DURA PATCH REMOVED EIGHT YEARS AFTER PITUITARY SURGERY" PUBLISHED BY BRITISH JOURNAL OF NEUROSURGERY, 2016 HTTP://DX.DOI.ORG/10.3109/02688697.2015.1122171., IT WAS REPORTED THAT XXXXXX. PER THE ABSTRACT: "THE CODMAN ETHISORB DURA PATCH IS A SYNTHETIC, ABSORBABLE MATERIAL WHOSE ABSORPTION IS COMPLETE WITHIN APPROXIMATELY 90 DAYS. WE REPORT THE FIRST CASE OF AN UNABSORBED CODMAN DURA PATCH, IN WHICH A PATIENT WAS PRESENTED WITH NASAL OBSTRUCTION AND EPISTAXIS 8 YEARS AFTER PITUITARY SURGERY FOR CUSHING'S DISEASE." ALSO PER THE ARTICLE: "A (B)(6) CAUCASIAN MALE PRESENTED TO HIS LOCAL CASUALTY DEPARTMENT WITH NASAL OBSTRUCTION AND SEVERE EPISTAXIS. HE HAD A HISTORY OF PITUITARY SURGERY AFTER UNDERGOING A TRANSSPHENOIDAL APPROACH FOR CUSHING'S DISEASE 8 YEARS PRIOR. UPON EXAMINATION WITH A NASOENDOSCOPE, A NASAL LESION WAS SEEN IN HIS RIGHT NASAL CAVITY..... THE FOREIGN BODY WAS REMOVED UNDER ANESTHETIC AND THE OPERATING SURGEON, WHO WAS NOT A SKULL BASE SURGEON, THOUGHT THIS COULD BE A GAUZE SWAB THAT HAD INADVERTENTLY BEEN LEFT IN THE PATIENT. THE PATIENT WAS REFERRED TO OUR UNIT FOR FURTHER INVESTIGATION... INVESTIGATION INTO THE ORIGINAL OPERATIVE NOTES SHOWED THAT THE ONLY MATERIALS THAT WERE USED WERE A CODMAN ETHISORB DURA PATCH, TO REPAIR AN INTRA-OPERATIVE CEREBROSPINAL FLUID (CSF) LEAK, AND A BISMUTH IODINE PARAFFIN PASTE (BIPP) NASAL PACK. THE BIPP PACK HOWEVER WAS REMOVED FIVE DAYS AFTER THE OPERATION AND THE PATIENT DENIED ANY SUBSEQUENT NASAL SURGERY. PATHOLOGICAL ANALYSIS OF THE FOREIGN BODY REVEALED IT TO BE A RECTANGULAR PIECE OF MEMBRANOUS MATERIAL MEASURING 4_3 CM, WHICH WAS CONSISTENT WITH SYNTHETIC DURAL PATCH MATERIAL. MICROSCOPY OF THE UNABSORBED DURA PATCH SHOWED IT TO BE ENCRUSTED WITH ACTINOMYCES-LIKE MICROORGANISMS." THERE IS NO REPORT OF FURTHER ISSUE FOR THIS PATIENT. AT THE TIME OF COMPLAINT ENTRY NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556499 ETHISORB DURA PATCH DURA SUBSTITUTE GXQ CODMAN & SHURTLEFF, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention