BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX 1S

    MDR report key: 23323099 · Received October 17, 2025

    Report

    Report Number
    3010513348-2025-00015
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 17, 2025
    Manufacturer
    AROA BIOSURGERY
    Product Code
    FTM
    UDI-DI
    09421904065086
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DYSPHAGIA AND PERFORATION (I.E. EROSION) ARE NOTED AS POSSIBLE ADVERSE EVENTS REPORTED ASSOCIATED WITH HERNIA REPAIR IN THE OVITEX INSTRUCTIONS FOR USE. A BATCH RECORD REVIEW SHOWED NO NON-CONFORMANCES OR ANOMALIES THAT MAY HAVE 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 IN (B)(6) 2025 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
    300439 OVITEX 1S SURGICAL MESH FTM AROA BIOSURGERY F10246-0610P ERT-24I19 09421904065086

    Patients

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