BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX 1S

    MDR report key: 23432855 · Received October 30, 2025

    Report

    Report Number
    3007321028-2025-00044
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 17, 2025
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    FTM
    UDI-DI
    09421904065086
    PMA / PMN Number
    K153632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AROA'S REVIEW OF MANUFACTURING DOCUMENTATION FOR THE SUBJECT LOT (ERT-24I19) HAS CONFIRMED THAT THE DEVICES WERE PRODUCED IN ACCORDANCE WITH THE ESTABLISHED PROCEDURES. ALL PROCESS SPECIFICATIONS AND FINAL RELEASE SPECIFICATIONS WERE SATISFIED. DYSPHAGIA AND PERFORATION 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT HIATAL HERNIA REPAIR WITH OVITEX 1SP AND THE LINX REFLUX MANAGEMENT SYSTEM ON (B)(6) 2025. THE PATIENT PRESENTED WITH DYSPHAGIA AND RETURNED FOR ENDOSCOPY ON (B)(6) 2025 WHERE POTENTIAL ENTRY INTO THE ESOPHAGUS WAS NOTED. THE SURGEON NOTED THAT THEY PLAN TO PERFORM AN ADDITIONAL ENDOSCOPY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1701731 OVITEX 1S SURGICAL MESH FTM AROA BIOSURGERY LTD. F10246-0610P ERT-24I19 09421904065086

    Patients

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