BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSORB BTM

    MDR report key: 14838956 · Received June 28, 2022

    Report

    Report Number
    3007886187-2022-00002
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    June 21, 2022
    Report Date
    October 6, 2022
    Manufacturer
    POLYNOVO BIOMATERIALS PTY LTD
    Product Code
    FRO
    PMA / PMN Number
    K172140
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ALTERNATE SURGICAL APPROACH REQUIRED BECAUSE THE BTM HAD NOT SUFFICIENTLY INTEGRATED. FURTHER DETAILS ARE PENDING. DELAYED INTEGRATION BECAUSE OF A LACK OF VIABLE WOUND BED OR OTHER COMPLICATION IS DESCRIBED IN THE IFU. HOWEVER, IN THIS CASE IT IS NOT EXPECTED AS WOUND PREPARATION (BONE BURRING) LOOKS TO HAVE BEEN ADEQUATE.

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE DEVICE WAS UNAVAILABLE FOR EVALUATION, A REVIEW OF BATCH 190702L5 HAS BEEN CONDUCTED AND NO ERRORS WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT IS REPORTED THAT BTM HAD NOT (COMPLETELY) INTEGRATED AFTER 7 WEEKS ADDING THAT THERE HAD BEEN BURRING OF THE OUTER TABLE. IT WAS REPORTED THAT A FREE FLAP WAS USED AND LARGE AREAS OF BTM WAS REMOVED. THE REPORTER ALSO STATED THAT HE WAS UNSURE WHY THE BTM HAD NOT INTEGRATED AND COMMENTED THAT THE PATIENT WAS VERY FIT, COMPLIANT AND A NON-SMOKER. EVENT RESOLUTION IS RESOLVED. ACTION TAKEN WITH THE DEVICE WAS AS PARTIALLY REMOVED AND NOT REPLACED.

    Description of Event or Problem · 0

    THE REPORTER STATED THE INDICATION FOR NOVOSORB BTM USE WAS EXCISION OF A SKIN CANCER, AND THAT THE CAUSE OF DELAY IN INTEGRATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938012 NOVOSORB BTM WOUND DRESSING FRO POLYNOVO BIOMATERIALS PTY LTD BTM-1020 190702L5

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention