BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX 1S

    MDR report key: 23921942 · Received December 30, 2025

    Report

    Report Number
    3010513348-2025-00020
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    September 9, 2025
    Report Date
    December 30, 2025
    Manufacturer
    AROA BIOSURGERY
    Product Code
    FTM
    UDI-DI
    09421904065116
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HERNIA RECURRENCE IS A POTENTIAL COMPLICATION AFTER HERNIA REPAIR WITH OR WITHOUT THE USE OF SUPPORTING MATERIAL AND IS NOTED AS A POTENTIAL COMPLICATION IN THE OVITEX INSTRUCTIONS FOR USE. IT CANNOT BE DETERMINED WHETHER THE DEVICE OR OTHER PATIENT FACTORS, HISTORY, AND COMORBIDITIES CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2024. THE PRIMARY REPAIR INCLUDED INCARCERATED BOWEL WHICH WAS REDUCED AND PRIMARY CLOSURE OBTAINED. THE PATIENT PRESENTED WITH A BULGE IN THE SUPRAUMBILICAL AREA IN (B)(6) 2025 WITH SUSPECTED HERNIA RECURRENCE. THE HERNIA WAS REDUCED AND REPAIRED ON (B)(6) 2025 VIA A ROBOTIC TAPP HERNIA REPAIR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768843 OVITEX 1S SURGICAL MESH FTM AROA BIOSURGERY F10246-1620P 09421904065116

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Hospitalization