BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSORB BTM

    MDR report key: 22935629 · Received September 2, 2025

    Report

    Report Number
    3007886187-2025-00022
    Event Type
    Injury
    Date Received
    September 2, 2025
    Report Date
    September 1, 2025
    Manufacturer
    POLYNOVO BIOMATERIALS PTY LTD
    Product Code
    QSZ
    PMA / PMN Number
    K172140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 OR THE WAY IT WAS USED. THE REPORTED ISSUE IS A KNOWN RISK ASSOCIATED WITH THE USE OF THE DEVICE. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY IDENTIFIED. 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

    IT WAS REPORTED THAT THE PATIENT SUSTAINED A ROAD TRAFFIC ACCIDENT, RESULTING IN MULTIPLE DEGLOVING INJURIES. CLINICAL APPEARANCE OF THE WOUND IN THE RIGHT OCCIPITAL BONE ON THE DATE OF INJURY, WITH EXPOSED CALVARIUM. BTM APPLICATION FOR OCCIPITAL BONE COVERAGE 15 DAYS AFTER THE INITIAL INJURY. BTM STARTED INCORPORATION AFTER 14 DAYS LATER. AN STSG WAS APPLIED 24 DAYS POST BTM APPLICATION. SKIN GRAFT FAILURE ON TOP OF BTM 12 DAYS LATER, REQUIRING RE-GRAFTING. SECOND STSG FULLY TAKEN 12 DAYS AFTER RE-GRAFTING. WOUND FULLY HEALED, ONGOING OT AND SCAR CARE. ANY OMITTED INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. PLEASE REFERENCE HTTPS://DOI.ORG/10.3390/JCM14155427.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828340 NOVOSORB BTM Absorbable synthetic wound dressing QSZ POLYNOVO BIOMATERIALS PTY LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Female Required Intervention