BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX 1S

    MDR report key: 23241431 · Received October 7, 2025

    Report

    Report Number
    3007321028-2025-00043
    Event Type
    Injury
    Date Received
    October 7, 2025
    Report Date
    October 1, 2025
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    FTM
    PMA / PMN Number
    K153632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AROA'S REVIEW OF MANUFACTURING DOCUMENTATION FOR THE SUBJECT LOT (ERT-24E13) HAS CONFIRMED THAT THE DEVICES WERE PRODUCED IN ACCORDANCE WITH THE ESTABLISHED PROCEDURES. ALL PROCESS SPECIFICATIONS AND FINAL RELEASE SPECIFICATIONS WERE SATISFIED. ADHESION AND BOWEL OBSTRUCTION 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 HERNIA 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
    2586710 OVITEX 1S SURGICAL MESH FTM AROA BIOSURGERY LTD. F10246-1020P ERT-24E13

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R