BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSORB BTM

    MDR report key: 23254993 · Received October 9, 2025

    Report

    Report Number
    3007886187-2025-00030
    Event Type
    Injury
    Date Received
    October 9, 2025
    Manufacturer
    POLYNOVO BIOMATERIALS PTY LTD
    Product Code
    QSZ
    PMA / PMN Number
    K172140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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 BATCH REVIEW WAS PERFORMED FOR LOT# 241108AL5, AND IT WAS CONCLUDED THAT THERE WERE NO ISSUES WERE IDENTIFIED WITHIN THE MANUFACTURING AND DISTRIBUTION PROCESS FOR BATCH 241108AL5 THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. FOLLOWING THE RISK PROFILE REVIEW, THE REPORTED ISSUE IS NOT UNCOMMON WITH SIMILAR PROCEDURES (COMPARATORS), POLYNOVO WAS UNABLE TO DEFINITIVELY IDENTIFY THE UNDERLYING CAUSE OR ESTABLISH THAT THE DEVICE CONTRIBUTED TO THE EVENT BASED ON LIMITED INFORMATION RECEIVED. THEREFORE, THE DECISION TO REPORT THIS EVENT WAS BASED OUT OF ABUNDANCE OF CAUTION DUE TO LACK OF SUFFICIENT (EVENT CLARIFICATION) AT THE TIME OF THIS REPORT. 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. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY IDENTIFIED DUE TO LIMITED INFORMATION RECEIVED. 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

    THE "PATIENT DEVELOPED A PYOGENIC GRANULOMA IN THE SITE OF BTM. BTM APPLICATION (B)(6) AFFIXED WITH SUTURES, DRESSED IN XEROFORM BOLSTER. LOOKED AS EXPECTED AT 1 WEEK OUT. KEPT XEROFORM BOLSTER. NEVER SHARED WHEN THE BTM DELAMINATED. PRESENTED WITH GRANULOMA AT THREE MONTH VISIT, NOT COMMUNICATED WITH ME WHEN THE PATIENT FIRST SAW IT. THE SURGEON ALSO SAID SHE IS NOT CONCERNED ABOUT IT. IN ADDITIONAL INFORMATION, SURGEON CONFIRMED THAT THE PATIENT WAS "FINE" AND SHE "CHEMICALLY CAUTERIZED IT IN THE OFFICE AND IT'S GONE, HE HAS A SCAB THERE BUT LOOKS GOOD OVERALL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2609670 NOVOSORB BTM Absorbable synthetic wound dressing QSZ POLYNOVO BIOMATERIALS PTY LTD BTM-0505 241108AL5

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention