BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSORB BTM

    MDR report key: 23129634 · Received September 23, 2025

    Report

    Report Number
    3007886187-2025-00029
    Event Type
    Injury
    Date Received
    September 23, 2025
    Report Date
    September 24, 2025
    Manufacturer
    POLYNOVO BIOMATERIALS PTY LTD
    Product Code
    QSZ
    PMA / PMN Number
    K172140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT AVAILABLE AND THEREFORE A DEVICE EVALUATION COULD NOT BE PERFORMED. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE COMPLETED AS A LOT NUMBER WAS NOT PROVIDED. A HIGH-LEVEL ANALYSIS WAS PERFORMED AND THERE WERE NO NON-CONFORMITIES FOUND TO BE RELATED TO THE REPORTED EVENT. A REVIEW OF THE DEVICE¿S RISK PROFILE SUGGESTS THE REPORTED EVENT DOES NOT CONSTITUTE A NEW HARM OR HAZARD. AN ADVERSE EVENT APPEARS TO HAVE OCCURRED BUT DOES NOT APPEAR TO HAVE BEEN A PROBLEM WITH THE DEVICE. BASED ON THE DETAILS AVAILABLE THE ROOT CAUSE FOR THE REPORTED COMPLAINT WAS DUE TO THE DEVICE BEING IMPLANTED UPSIDE DOWN DUE TO USE ERROR. THE RISK IS ADEQUATELY DOCUMENTED FOR THIS COMPLAINT. THE IFU (IFU-008) INCLUDES PLACEMENT INSTRUCTIONS FOR THE BTM: ¿TAKING CARE TO HAVE THE SMOOTH SEALING MEMBRANE SIDE OUTERMOST, THE FOAM SIDE CAN BE PRESSED INTO THE WOUND¿¿ AND ¿THE NOVOSORB® BTM IS LAID INTO THE WOUND, SEALING MEMBRANE SIDE OUT". THE IFU ADEQUATELY PROVIDES INSTRUCTIONS FOR IMPLANTATION, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. POLYNOVO COULD NOT CONFIRM A DETERIORATION OR CHANGE IN THE CHARACTERISTICS OR PERFORMANCE, OR INACCURACIES IN THE LABELLING OR INSTRUCTION FOR THE REPORTED CASE. THE RATE OF THE REPORTED ISSUE TO POLYNOVO IS CONSIDERED LOW AND ACCEPTABLE. THE CLINICAL BENEFITS CONTINUE TO OUTWEIGH THE POTENTIAL RISKS ASSOCIATED WITH THIS HAZARD/USE OF THE DEVICE. NO TREND OR DEFICIENCY HAS BEEN IDENTIFIED. POLYNOVO DOES NOT BELIEVE THAT A CORRECTIVE ACTION IS WARRANTED. POLYNOVO WILL CONTINUE TO INVESTIGATE AND MONITOR COMPLAINTS OF THIS NATURE. MFR REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    A SURGEON REPORTED THAT A REGISTRAR COMPLETED A SURGICAL CASE BUT DID NOT DISCLOSE THEIR IDENTITY. THE PHOTO INDICATED THAT THE BTM APPEARED TO HAVE BEEN PLACED UPSIDE DOWN, AS NO VISIBLE FOAM WAS PRESENT AND THERE WAS NO INTEGRATION. BTM WAS APPLIED TO THE SCALP OVER THE PERIOSTEUM FOLLOWING A SKIN CANCER EXCISION, WITH A BTM-1010 BEING USED. THE SURGEON MENTIONED THAT TRACKING DOWN THE LOT NUMBER WOULD NOT BE POSSIBLE. AT SEVEN WEEKS POST-PROCEDURE, THERE WAS NO EVIDENCE OF INTEGRATION. IT WAS NOTED THAT THE BTM SEALING MEMBRANE WAS DRIED AND ADHERED TO THE BONE, AND THE SURGEON OBSERVED THAT THE BTM FOAM BETWEEN THE PERIOSTEUM AND SEALING MEMBRANE HAD LIKELY DISINTEGRATED AND WAS NO LONGER PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200623 NOVOSORB BTM Absorbable synthetic wound dressing QSZ POLYNOVO BIOMATERIALS PTY LTD BTM-1010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention