BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX 1S

    MDR report key: 22877982 · Received August 22, 2025

    Report

    Report Number
    3010513348-2025-00013
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    June 29, 2025
    Report Date
    August 14, 2025
    Manufacturer
    AROA BIOSURGERY
    Product Code
    FTM
    UDI-DI
    09421904065130
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADHESIONS ARE A COMMON POST OPERATIVE COMPLICATION OF ABDOMINAL SURGERY AND MAY SOMETIMES LEAD TO BOWEL OBSTRUCTION AND/OR SMALL BOWEL RESECTION. IT COULD NOT BE DEFINITIVELY DETERMINED WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENTS NOTED. A BATCH RECORD (LOT) REVIEW SHOWED NO NON-CONFORMANCES OR ANOMALIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS NOTED. THIS LOT WAS STERILIZED WITH THE APPROPRIATE VALIDATED STERILIZATION CYCLE AND ALL RELEASE TESTING WAS ACCEPTABLE. ALL INFORMATION KNOWN AT THE TIME OF THIS REPORT IS INCLUDED. NO FURTHER INFORMATION WAS PROVIDED BY THE REPORTING SURGEON.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A HERNIA REPAIR (IPOM) WITH OVITEX 1S PERMANENT IN APPROXIMATELY (B)(6) 2025. THE CASE WAS PLANNED TO BE LAPAROSCOPIC BUT WAS CONVERTED TO OPEN. ON (B)(6) 2025, THE PATIENT RETURNED TO THE EMERGENCY ROOM AND WAS TAKEN IN FOR SURGERY. DURING THIS SURGERY, THE SURGICAL SITE APPEARED INFECTED AND ADHESIONS WERE PRESENT. THE DEVICE WAS REMOVED AND A SMALL BOWEL RESECTION PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2456916 OVITEX 1S SURGICAL MESH FTM AROA BIOSURGERY F10246-2020P ERT-24I03 09421904065130

    Patients

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