BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX 1S

    MDR report key: 23511899 · Received November 10, 2025

    Report

    Report Number
    3007321028-2025-00046
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    October 15, 2025
    Report Date
    October 31, 2025
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    FTM
    UDI-DI
    09421904065727
    PMA / PMN Number
    K181935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AROA WAS UNABLE TO CONDUCT A REVIEW OF MANUFACTURING DOCUMENTATION SINCE THE LOT NUMBER FOR THE DEVICE WAS AVAILABLE. A REVIEW OF THE RISK MANAGEMENT FILE DETERMINED NO ADDITIONAL RISK CONTROL MEASURES ARE WARRANTED . ABSCESS AND FISTULA ARE NOTED AS POTENTIAL COMPLICATIONS IN THE INSTRUCTIONS FOR USE OF THE DEVICE. THERE WAS NO EVIDENCE TO INDICATE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A DUAL ANASTOMOSIS CASE ON (B)(6) 2024, DURING WHICH ANASTOMOSES WERE PERFORMED ON THE UPPER AND LOWER COLON. AFTER THIS, A COMPLEX ABDOMINAL WALL CLOSURE WAS CONDUCTED. THE LOWER ANASTOMOSIS LEAKED AND THE PATIENT WAS READMITTED ON (B)(6) 2024. A CT IDENTIFIED ABSCESS WAS DRAINED WITH A SECOND DRAINAGE ON (B)(6) 2024. A FISTULA FORMED FROM THIS LOWER ANASTOMOSIS. INTESTINAL FAILURE TREATMENT COMMENCED ALONG WITH TOTAL PARENTERAL NUTRITION AND SURGICAL SCLEROSIS OF THE FISTULA UNTIL WELL ENOUGH FOR REPAIR OF LOWER ANASTOMOSIS FISTULA WHICH WAS SCHEDULED FOR ON (B)(6) 2025. A SKIN FISTULA PRESENTED INCLUDING THE PRESENCE OF POLYPROPYLENE SUTURE. A REOPERATION WAS CONDUCTED TO REMOVE A PORTION OF SUTURE MATERIAL WITH THE ABDOMINAL WALL REPAIR NOTED TO BE INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927321 OVITEX 1S SURGICAL MESH FTM AROA BIOSURGERY LTD. F10246-2530P 09421904065727

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H