BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSORB BTM

    MDR report key: 23363827 · Received October 22, 2025

    Report

    Report Number
    3007886187-2025-00031
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Report Date
    October 23, 2025
    Manufacturer
    POLYNOVO BIOMATERIALS PTY LTD
    Product Code
    QSZ
    PMA / PMN Number
    K172140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 IDENTIFIERS WERE NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS FOR THIS DEVICE LOT NUMBER COULD NOT BE REVIEWED. 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. FOLLOWING THE RISK PROFILE REVIEW, THE REPORTED ISSUE IS KNOWN AND ASSOCIATED WITH THE PROCEDURE, POLYNOVO WAS UNABLE TO DEFINITIVELY IDENTIFY THE UNDERLYING CAUSE OR ESTABLISH THAT THE DEVICE CONTRIBUTED TO THE EVENT BASED ON LIMITED INFORMATION RECEIVED. THE IFU ADEQUATELY PROVIDES INSTRUCTIONS FOR STENT IMPLANTATION, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. BASED ON PERIODIC COMPLAINT TRENDING AND ANALYSIS, POLYNOVO COULD NOT CONFIRM A DETERIORATION OR CHANGE IN THE CHARACTERISTICS OR PERFORMANCE, OR INACCURACIES IN THE LABELING OR INSTRUCTION LEAFLET OF THE MEDICAL DEVICE FOR THE REPORTED EVENT. THE REPORTED EVENT IS A KNOWN OUTCOME OF THE PROCEDURE. 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 CONFIRMED NEGATIVE 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

    THE SURGEON REPORTED POSTOPERATIVE HYPER-GRANULATION AFTER REMOVING THE SEALING MEMBRANE OF BTM. WHILE AGENTS SUCH AS HYDROGEN BLUE, SILVER NITRATE, OR OVER-THE-COUNTER STEROID CREAMS WERE PREVIOUSLY USED, THESE ARE NOT THE PREFERRED INTERVENTIONS PER THE SURGEON. THE SURGEON NOTED AN INCREASE IN HYPER-GRANULATION WITH BTM. ALTHOUGH THE HYPER-GRANULATION TYPICALLY RESOLVES SPONTANEOUSLY, ISSUES SUCH AS WEB CREEP MAY ARISE. THE BTM SITE WAS MANAGED WITH XEROFORM, DRY DRESSING, AND A CAST FOR THREE WEEKS TO MAINTAIN PROTECTION. ADDITIONAL INFORMATION INDICATED THAT THE CONDITION GENERALLY RESOLVES AS TISSUE RE-EPITHELIALIZES. ADDITIONAL POSTOPERATIVE TREATMENT EVALUATION COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1835037 NOVOSORB BTM Absorbable synthetic wound dressing QSZ POLYNOVO BIOMATERIALS PTY LTD BTM-1010, BTM-0505

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention