BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX 1S

    MDR report key: 22881649 · Received August 24, 2025

    Report

    Report Number
    3007321028-2025-00038
    Event Type
    Injury
    Date Received
    August 24, 2025
    Date of Event
    June 29, 2025
    Report Date
    August 21, 2025
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    FTM
    UDI-DI
    09421904065130
    PMA / PMN Number
    K153632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AROA'S REVIEW OF MANUFACTURING DOCUMENTATION FOR THE SUBJECT LOT (ERT-24I03) HAS CONFIRMED THAT THE DEVICES WERE PRODUCED IN ACCORDANCE WITH THE ESTABLISHED PROCEDURES. ALL PROCESS SPECIFICATIONS AND FINAL RELEASE SPECIFICATIONS WERE SATISFIED. ADHESION, BOWEL OBSTRUCTION, AND INFECTION 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 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
    2486497 OVITEX 1S SURGICAL MESH FTM AROA BIOSURGERY LTD. F10246-2020P ERT-24I03 09421904065130

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R