BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURAMATRIX-ONLAY COLLAGEN DURA SUBSTITUTE MEMBRANE

    MDR report key: 22153930 · Received June 5, 2025

    Report

    Report Number
    2249852-2025-00007
    Event Type
    Death
    Date Received
    June 5, 2025
    Date of Event
    April 17, 2025
    Report Date
    June 17, 2025
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    GXQ
    PMA / PMN Number
    K061487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    LIMITED INFORMATION PROVIDED. CLINICAL DATA COLLECTION SITE REPORTED A "DM/DMO" PRODUCT WAS USED ON A PATIENT FOR A MASS RESECTION ON (B)(6) 2025. NO PRODUCT ITEM NUMBER, PRODUCT LOT NUMBER, OR SPECIFIC PRODUCT NAME WAS PROVIDED. MEDICAL INTERVENTION REQUIRED AND A DECOMPRESSIVE HEMICRANIECTOMY WAS PERFORMED ON (B)(6) 2025. VARIOUS HOSPITAL COMPLICATIONS WERE REPORTED (SEE ATTACHED DOCUMENT FOR ALL REPORTED PATIENT INFORMATION). PATIENT EXPERIENCED ACUTE SEVERE NEUROLOGIC DECLINE ON (B)(6) 2025 AND BECAME HYPOTENSIVE, LIKELY FROM SEPTIC SHOCK. PATIENT WAS TERMINALLY EXTUBATED AND PASSED SHORTLY THEREAFTER ON (B)(6) 2025. IT WAS NOTED THAT "RELATIONSHIP OF THE EVENT" (EVENT OF SEPTIC SHOCK) TO THE INTERVENTION IS UNRELATED. CLINICIAN DOES NOT BELIEVE THERE IS CORRELATION BETWEEN THE "DM/DMO" PRODUCT AND THE SEPTIC SHOCK. NO ADDITIONAL EVENT, PRODUCT, OR PATIENT INFORMATION PROVIDED.

    Description of Event or Problem · 0

    LIMITED INFORMATION PROVIDED. COMPLAINT WAS SUBMITTED THROUGH CLINICAL DATA COLLECTION. THE CLINICAL DATA COLLECTION SITE REPORTED A DURAMATRIX ONLAY PRODUCT WAS USED ON A PATIENT FOR A MASS RESECTION ON (B)(6) 2025. MEDICAL INTERVENTION REQUIRED AND A DECOMPRESSIVE HEMICRANIOMOTOMY WAS PERFORMED ON (B)(6) 2025. VARIOUS HOSPITAL COMPLICATIONS WERE REPORTED (SEE ATTACHED DOCUMENT FOR ALL REPORTED PATIENT INFORMATION). PATIENT EXPERIENCED ACUTE SEVERE NEUROLOGIC DECLINE ON (B)(6) 2025 AND BECAME HYPOTENSIVE, LIKELY FROM SEPTIC SHOCK. PATIENT WAS TERMINALLY EXTUBATED AND PASSED SHORTLY THEREAFTER ON (B)(6) 2025. IT WAS NOTED THAT "RELATIONSHIP OF THE EVENT" (EVENT OF SEPTIC SHOCK) TO THE INTERVENTION IS UNRELATED. CLINICIAN DOES NOT BELIEVE THERE IS CORRELATION BETWEEN THE PRODUCT AND THE SEPTIC SHOCK/PATIENT DEATH. NO ADDITIONAL EVENT OR PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344573 DURAMATRIX-ONLAY COLLAGEN DURA SUBSTITUTE MEMBRANE COLLAGEN DURA SUBSTITUTE MEMBRANES GXQ COLLAGEN MATRIX, INC. CDSLM13 2407031022

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Required Intervention| O| D