BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX 1S

    MDR report key: 23191551 · Received October 1, 2025

    Report

    Report Number
    3010513348-2025-00014
    Event Type
    Injury
    Date Received
    October 1, 2025
    Report Date
    October 1, 2025
    Manufacturer
    AROA BIOSURGERY
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADHESIONS AND BOWEL OBSTRUCTION ARE KNOWN COMPLICATIONS OF HERNIA SURGERY WHERE BOWEL IS CONTACTED. ADHESION AND BOWEL OBSTRUCTION ARE NOTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL COMPLICATIONS ASSOCIATED WITH SURGICAL REPAIR OF HERNIAS WITH OR WITHOUT THE USE OF SURGICAL MESH. NO INFORMATION PROVIDED SUGGESTS THAT THE OVITEX DEVICE DEFINITIVELY CAUSED THE EVENT NOTED.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT HERNIA REPAIR WITH OVITEX 1S ON (B)(6) 2025. IT WAS REPORTED THAT IN APPROXIMATELY (B)(6) 2025, THE PATIENT RETURNED AND REQUIRED RE-OPERATION WHERE A BOWEL OBSTRUCTION WAS NOTED WITH SOME ADHESIONS PRESENT. NO BOWEL RESECTION OR PERMANENT DAMAGE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154644 OVITEX 1S SURGICAL MESH FTM AROA BIOSURGERY F10246-1020P ERT-24E13

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R