BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVITEX REINFORCED TISSUE MATRIX

    MDR report key: 17814836 · Received September 25, 2023

    Report

    Report Number
    3007321028-2023-00024
    Event Type
    Death
    Date Received
    September 25, 2023
    Date of Event
    August 21, 2023
    Report Date
    September 25, 2023
    Manufacturer
    AROA BIOSURGERY LTD
    Product Code
    FTL
    UDI-DI
    09421904065130
    PMA / PMN Number
    K153632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT DIED FROM COMPLICATIONS OF NECROTIZING ENTEROCOLITIS APPROXIMATELY THREE WEEKS AFTER ROBOTIC PARASTOMAL SUGARBAKER HERNIA REPAIR AND ONE WEEK AFTER ONSET OF ENTEROCOLITIS. THE PATIENT WAS DEBRIDED MULTIPLE TIMES UNSUCCESSFULLY AND IT WAS NOTED THAT THE OVITEX DEVICE WAS INTACT. NECROTIZING ENTEROCOLITIS IS AN EXTREMELY RARE COMPLICATION IN ADULT PATIENTS AND IT IS POSSIBLE THAT THE COMPLICATION WAS TRULY NECROTIZING FASCIITIS.THE OVITEX DEVICE IS HIGHLY UNLIKELY TO HAVE CONTRIBUTED TO THESE EVENTS, WHICH ARE GENERALLY CAUSED BY INFECTION. THE OVITEX DEVICE WAS REPORTED INTACT AND IS TERMINALLY STERILIZED WITH A VALIDATED STERILIZATION CYCLE. IN AN ABUNDANCE OF CAUTION, THIS EVENT IS BEING REPORTED BASED ON THE PATIENT OUTCOME.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT ROBOTIC PARASTOMAL SUGARBAKER HERNIA REPAIR ON (B)(6) 2023 WITH OVITEX. ON (B)(6) 2023, THE PATIENT PRESENTED WITH NECROTIZING ENTEROCOLITIS. THE PATIENT WAS DEBRIDED MULTIPLE TIMES. THE PATIENT PASSED AWAY APPROXIMATELY ONE WEEK LATER. IT WAS REPORTED THAT THE OVITEX DEVICE WAS INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723583 OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH FTL AROA BIOSURGERY LTD F10246-2020P ERT-22L03 09421904065130

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| H