BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSORB MTX

    MDR report key: 22572997 · Received July 22, 2025

    Report

    Report Number
    3007886187-2025-00019
    Event Type
    Injury
    Date Received
    July 22, 2025
    Report Date
    July 23, 2025
    Manufacturer
    POLYNOVO BIOMATERIALS PTY LTD
    Product Code
    QSZ
    UDI-DI
    09349155001281
    PMA / PMN Number
    K221686
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT AVAILABLE; THEREFORE, PRODUCT TESTING ON THE ACTUAL DEVICE COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD REVIEW OF THE MANUFACTURING LOT WAS PERFORMED AND THERE WERE NO NON-CONFORMITIES FOUND TO BE RELATED TO THE REPORTED EVENT. A REVIEW OF THE DEVICE RISK DOCUMENT WAS PERFORMED. THE REPORTED ISSUE IS KNOWN RISK ASSOCIATED WITH THE PROCEDURE. AN ADVERSE EVENT APPEARS TO HAVE OCCURRED BUT DOES NOT APPEAR TO HAVE BEEN A PROBLEM WITH THE DEVICE OR THE WAY IT WAS USED. THE IFU ADEQUATELY PROVIDES INSTRUCTIONS FOR STENT IMPLANTATION, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. THE RATE OF THE REPORTED EVENT TO POLYNOVO IS CONSIDERED LOW AND ACCEPTABLE. THE CLINICAL BENEFITS CONTINUE TO OUTWEIGH THE POTENTIAL RISKS ASSOCIATED WITH THE USE OF THE DEVICE. NO TREND OR DEFICIENCY HAS BEEN IDENTIFIED. BASED ON THE INFORMATION RECEIVED AT THE TIME OF THIS REPORT, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY IDENTIFIED. MFR REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MTX WAS NON ADHERENT A MONTH AFTER IT WAS APPLIED. THE MTX WAS REMOVED FROM THE WOUND BED. ANY OMITTED INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2725665 NOVOSORB MTX Absorbable synthetic wound dressing QSZ POLYNOVO BIOMATERIALS PTY LTD MTX-1010 230327AM1 09349155001281

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention