BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSORB BTM

    MDR report key: 23483166 · Received November 5, 2025

    Report

    Report Number
    3007886187-2025-00032
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 7, 2025
    Report Date
    October 7, 2025
    Manufacturer
    POLYNOVO BIOMATERIALS PTY LTD
    Product Code
    QSZ
    PMA / PMN Number
    K172140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 FOR LOT #240429AL4 WAS PERFORMED AND CONCLUDED THAT NO ISSUES WERE IDENTIFIED IN THE MANUFACTURING OR DISTRIBUTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. BASED ON THE DETAILS AVAILABLE, THE ROOT CAUSE OF THE ADVERSE EVENT WAS DUE TO USER ERROR AS THE VAC TAPE WAS PLACED OVER THE IMPLANTED BTM DURING DRESSING CHANGE, RESULTING IN A PORTION OF THE BTM ADHERING TO THE TAPE AND BEING UNINTENTIONALLY RIPPED OFF AND WAS NOT SALVAGEABLE. 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 ANY INACCURACIES IN THE LABELLING OR INSTRUCTION LEAFLET, OF THE MEDICAL DEVICE FOR THE REPORTED EVENT. THE INFORMATION RECEIVED DOES NOT SUGGEST A PROBLEM WITH THE DEVICE. THE CLINICAL BENEFITS CONTINUE TO OUTWEIGH THE POTENTIAL RISKS ASSOCIATED WITH THE USE OF THE DEVICE. NO TREND OR DEFICIENCY HAS BEEN IDENTIFIED. THERE IS NO PRODUCT RISK, CORRECTIVE ACTIONS ARE NOT REQUIRED, AND THE CASE WILL BE SUBJECT TO TRENDING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE RE-EVALUATED. MFR REFERENCE# (B)(4).

    Description of Event or Problem · 0

    AT DRESSING CHANGE ON AN UNSPECIFIED DATE, THE DRESSINGS WERE CHANGED/TAKEN OFF. VAC TAPE WAS PLACED OVER THE BTM ON THE PATIENT'S LEFT SIDE AND A PORTION OF BTM RIPPED OFF WITH IT. ON 07-OCT-2025 ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT DRESSING CHANGE (DATE OF EVENT) WAS 24-SEP-2025. THE TYPE OF WOUND WAS VENOUS STASIS ULCER ABOVE THE PATIENT'S ANKLE (NEARLY CIRCUMFERENTIAL). BTM WAS APPLIED WITH SUTURES. THE BTM THAT WAS TORN OFF WAS NOT SALVAGEABLE AND DISPOSED OF. A NEW PIECE OF BTM WAS APPLIED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2460354 NOVOSORB BTM Absorbable synthetic wound dressing QSZ POLYNOVO BIOMATERIALS PTY LTD BTM-1020 240429AL4

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention