BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX 2S

    MDR report key: 22628194 · Received July 28, 2025

    Report

    Report Number
    3007321028-2025-00026
    Event Type
    Injury
    Date Received
    July 28, 2025
    Date of Event
    July 10, 2025
    Report Date
    July 24, 2025
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    FTM
    UDI-DI
    09421904065161
    PMA / PMN Number
    K153632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AROA'S REVIEW OF MANUFACTURING DOCUMENTATION FOR THE SUBJECT LOT (ERT-21H07) HAS CONFIRMED THAT THE DEVICES WERE PRODUCED IN ACCORDANCE WITH THE ESTABLISHED PROCEDURES. ALL PROCESS SPECIFICATIONS AND FINAL RELEASE SPECIFICATIONS WERE SATISFIED. INFECTION AND SEROMA 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 EXPERIENCED CELLULITIS AND FLUID BUILD UP APPROXIMATELY 1.5 YEARS AFTER HERNIA REPAIR WITH OVITEX 2S. THE FLUID WAS POSITIVE FOR E. COLI AND PREVOTELLA AFTER INCISION DRAINAGE. THE FLUID COLLECTION PERSISTED, AND THE SURGEON PERFORMED A RE-OPERATION TO ADDRESS AND REMOVED SOME POLYPROPYLENE SUTURE. NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685840 OVITEX 2S SURGICAL MESH FTM AROA BIOSURGERY LTD. F10248-1012P ERT-21H07 09421904065161

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R