BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX 2S

    MDR report key: 22578650 · Received July 23, 2025

    Report

    Report Number
    3010513348-2025-00008
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    July 10, 2025
    Report Date
    July 23, 2025
    Manufacturer
    AROA BIOSURGERY
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A BATCH RECORD REVIEW PERFORMED SHOWED NO NON-CONFORMANCES OR ANOMALIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. INFECTION AND ABSCESS ARE KNOWN RISKS OF HERNIA SURGERY. THE INFORMATION SUBMITTED REPRESENTS ALL INFORMATION REASONABLY KNOWN TO TELA BIO AT THE TIME OF SUBMISSION.

    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 AND 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
    2293556 OVITEX 2S SURGICAL MESH FTM AROA BIOSURGERY F10248-1012P ERT-21H07

    Patients

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