BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL, UNKNOWN

    MDR report key: 24845384 · Received April 10, 2026

    Report

    Report Number
    3003418325-2026-00010
    Event Type
    Injury
    Date Received
    April 10, 2026
    Report Date
    May 29, 2026
    Manufacturer
    INTEGRA - PRINCETON
    Product Code
    NQR
    PMA / PMN Number
    P040034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    JOURNAL OF NEUROSURGERY PUBLISHED AN ARTICLE TITLED: ¿DURAL SEALANT-OMA¿ AFTER POSTERIOR FOSSA SURGERY: ILLUSTRATIVE CASE". BACKGROUND: DURAL SEALANTS, WIDELY USED IN NEUROSURGICAL PRACTICE, HAVE BEEN ASSOCIATED WITH FEW COMPLICATIONS, MOSTLY RELATING TO THE EXPANSIVE NATURE OF THE HYDROGEL. ALTHOUGH GENERALLY WELL TOLERATED, DURASEAL EXPANDS UP TO 150% AFTER APPLICATION, AND RARE REPORTS HAVE DESCRIBED COMPLICATIONS FROM MASS EFFECT. ADVERSE EVENT: THIS REPORT PRESENTS THE CASE OF A 34-YEAR-OLD FEMALE WITH A PAST SURGICAL HISTORY OF MULTIPLE OPERATIONS FOR A CHIARI TYPE 1 MALFORMATION. AFTER A THOROUGH WORKUP, INTRAOPERATIVE IMAGES AND HISTOLOGICAL FINDINGS REVEALED A CONCEALED HEMATOMA-LIKE MASS AT THE PATIENT¿S PREVIOUS SURGICAL SITE, LIKELY DUE TO THE DURASEAL SYSTEM. IMAGING REVEALED THAT THE DURASEAL WAS MOSTLY HYPERINTENSE ON T2-WEIGHTED MRI WITH FOCAL SPOTS OF HYPO-/ISOINTENSITY, SIMILAR IN APPEARANCE TO AN ABSCESS OR HEMATOMA. HISTOLOGICAL ANALYSIS SHOWED EXUBERANT FIBROSIS, GRANULATION TISSUE, AND A GRANULOMATOUS RESPONSE TO THE FOREIGN MATERIAL USED FOR THE DURAL PATCH AND SEAL RATHER THAN THE WALL OF AN INFECTIOUS ABSCESS. CONCLUSION: THIS CASE ADDS TO THE GROWING BODY OF LITERATURE ON DURASEAL, HIGHLIGHTING THE IMAGING AND HISTOLOGICAL CHARACTERISTICS OF ¿DURAL SEALANT-OMAS¿ AND THEIR EXPANSILE NATURE THAT CAN LEAD TO THE FORMATION OF A MASS MIMICKING AN ABSCESS OR A HEMATOMA. IN AREAS SUSCEPTIBLE TO COMPRESSION, CLINICIANS OUGHT TO BE VIGILANT TO IDENTIFY FINDINGS CONSISTENT WITH THE APPEARANCE OF THESE DURAL SEALANT-OMAS. HTTPS://THEJNS.ORG/DOI/ABS/10.3171/CASE25574.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34561 DURASEAL, UNKNOWN DURAL REPAIR NQR INTEGRA - PRINCETON

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Other