BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSORB BTM

    MDR report key: 23653567 · Received November 26, 2025

    Report

    Report Number
    3007886187-2025-00036
    Event Type
    Injury
    Date Received
    November 26, 2025
    Report Date
    November 20, 2025
    Manufacturer
    POLYNOVO BIOMATERIALS PTY LTD
    Product Code
    QSZ
    PMA / PMN Number
    K172140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 AVAILABLE, 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

    A PROSPECTIVE COHORT STUDY WAS CONDUCTED AT THE (B)(6) SERVICE A 40-YEAR-OLD FEMALE PATIENT WHO HAD BTM (DEVICE SIZE, LOT NUMBER NOT SPECIFIED) IMPLANTED ON (B)(6) 2024 TO 3X HEALED WOUNDS ON THE NECK, LEFT AXILLA AND RIGHT AXILLA FROM SELF-IMMOLATION. THE WOUND SIZE WAS 57% TBSA. BTM WAS APPLIED TO 112CM2 ON THE NECK. AT 3 MONTHS, RESURFACED AREA WAS 55CM2; AT 6 MONTHS WAS 37.5CM2 (66.52% OVERALL CONTRACTION). BTM WAS APPLIED TO 38.5CM2 ON THE RIGHT AXILLA. AT 3 MONTHS, RESURFACED AREA WAS 18CM2; AT 6 MONTHS WAS 13.5CM2 (64.94% OVERALL CONTRACTION). BTM WAS APPLIED TO 42.5CM2 ON THE LEFT AXILLA. AT 3 MONTHS, RESURFACED AREA WAS 16CM2; AT 6 MONTHS WAS 17CM2 (60% OVERALL CONTRACTION). NO ADVERSE OUTCOMES SUCH AS BTM INFECTION OR GRAFT BREAKDOWN WERE REPORTED. THE STUDY WAS CONCLUDED AS LONG-TERM EFFICACY OF BTM FOR CONTRACTURE RELEASE WAS NOT DEMONSTRATED WITHIN THIS COHORT. WHILE BTM FACILITATES SAFE WOUND BED PREPARATION WITH RELIABLE GRAFT UPTAKE, SUSTAINED CONTRACTURE RELEASE WAS LIMITED IN THIS COHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148417 NOVOSORB BTM Absorbable synthetic wound dressing QSZ POLYNOVO BIOMATERIALS PTY LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention