BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED TISSUE MATRIX

    MDR report key: 19367296 · Received May 21, 2024

    Report

    Report Number
    3007321028-2024-00028
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    April 1, 2024
    Report Date
    May 21, 2024
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    FTM
    UDI-DI
    09421904065727
    PMA / PMN Number
    K181935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AROA'S REVIEW OF MANUFACTURING DOCUMENTATION FOR THE SUBJECT LOT (ERT-22L18) HAS CONFIRMED THAT THE DEVICES WERE PRODUCED IN ACCORDANCE WITH THE ESTABLISHED PROCEDURES, WITH ALL PROCESS AND FINAL RELEASE SPECIFICATIONS SATISFIED. ADHESION AND BOWEL OBSTRUCTION ARE NOTED AS POTENTIAL COMPLICATIONS IN THE INSTRUCTIONS FOR USE OF THE DEVICE. EXTENT AND STRENGTH OF ADHESIONS MAY DIFFER BASED ON THE PROCEDURE PERFORMED AND UNDERLYING PATIENT CONDITIONS AND MAY LEAD TO BOWEL OBSTRUCTION. THE SURGEON INDICATED THAT HE UTILIZES A LARGE NUMBER OF TACKS FOR SURGICAL MESH PLACEMENT AND IT IS POSSIBLE THAT THIS CONTRIBUTED TO THE ADHESIONS AND BOWEL OBSTRUCTION. THE SURGEON ALSO NOTED THAT NO BOWEL RESECTION WAS REQUIRED TO ADDRESS THE OBSTRUCTION. DATES OF IMPLANT AND EXPLANT ARE APPROXIMATE BASED ON THE INFORMATION RECEIVED FROM THE SURGEON.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A COMPLEX BRIDGED ROBOTIC VENTRAL IPOM (INTRAPERITONEAL ONLAY MESH) HERNIA REPAIR WITH OVITEX 1S PERMANENT ON APPROXIMATELY (B)(6) 2024. THE PATIENT RETURNED WITH ADHESIONS AND A BOWEL OBSTRUCTION ON APPROXIMATELY (B)(6) 2024 AND THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426403 OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH FTM AROA BIOSURGERY LTD. F10246-2530P ERT-22L18 09421904065727

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R