BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSORB BTM

    MDR report key: 19571278 · Received June 19, 2024

    Report

    Report Number
    3007886187-2024-00005
    Event Type
    Injury
    Date Received
    June 19, 2024
    Report Date
    June 20, 2024
    Manufacturer
    POLYNOVO BIOMATERIALS PTY LTD
    Product Code
    QSZ
    UDI-DI
    09349155000161
    PMA / PMN Number
    K172140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A BATCH REVIEW WAS PERFORMED THE LOT AND IT WAS CONCLUDED THAT THERE WERE NO EVENTS ASSOCIATED WITH MANUFACTURING THAT COULD HAVE AFFECTED PRODUCT SAFETY AS BOTH BATCHES MET ALL SPECIFICATIONS AT THE TIME OF DISTRIBUTION. AS A RESULT OF THE INVESTIGATION, IT¿S BEEN CONCLUDED THERE IS NO PRODUCT RISK AND THE CASE WILL BE SUBJECT TO TRENDING ACCORDING TO DOCUMENTED PMS PROCEDURES.

    Description of Event or Problem · 0

    BTM WAS APPLIED USING SUTURES TO THE BILATERAL EXTREMITIES TO A PATIENT WITH ACUTE BURNS (OFF-LABEL USE) COVERING 55% OF TOTAL BODY SURFACE AREA (TBSA). ACTICOAT FLEX (SILVER-IMPREGNATED DRESSING) WAS USED ON THE ARMS IN CONJUNCTION WITH BTM, AND REGULAR ACTICOAT WAS USED FOR THE REST OF THE BURN AREAS WHERE BTM WAS NOT APPLIED. THE BTM INTEGRATED AND WAS SUBSEQUENTLY GRAFTED USING A SPLIT-THICKNESS SKIN GRAFT (STSG) AND RECELL (AUTOLOGOUS SKIN CELL SUSPENSION). HOWEVER, SHORTLY AFTER DISCHARGE, THE PATIENT DEVELOPED CONTRACTURES IN BOTH WRISTS AND ELBOWS WHICH REQUIRED SURGICAL INTERVENTION FOR THE CONTRACTURE RELEASE WHICH WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2193832 NOVOSORB BTM ABSORBABLE SYNTHETIC WOUND DRESSING QSZ POLYNOVO BIOMATERIALS PTY LTD BTM-2040 230707BL3 09349155000161

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention