BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED TISSUE MATRIX

    MDR report key: 19353852 · Received May 20, 2024

    Report

    Report Number
    3010513348-2024-00011
    Event Type
    Injury
    Date Received
    May 20, 2024
    Date of Event
    April 1, 2024
    Report Date
    May 20, 2024
    Manufacturer
    AROA BIOSURGERY
    Product Code
    FTM
    UDI-DI
    09421904065727
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADHESIONS ARE COMMON EVENTS AFTER ABDOMINAL SURGERY. EXTENT AND STRENGTH OF ADHESIONS MAY DIFFER BASED ON THE PROCEDURE PERFORMED AND UNDERLYING PATIENT CONDITIONS AND MAY LEAD TO BOWEL OBSTRUCTION. IT WAS REPORTED THAT ADHESIONS WERE DIFFICULT TO TAKE DOWN BUT NO BOWEL RESECTION WAS REQUIRED TO ADDRESS THE OBSTRUCTION. THE SURGEON NOTED THAT HE UTILIZES A LARGE NUMBER OF TACKS FOR SURGICAL MESH PLACEMENT AND IT IS POSSIBLE THAT THESE CONTRIBUTED TO THE ADHESIONS AND NOTED BOWEL OBSTRUCTION AS WELL. IT SHOULD BE NOTED THAT 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 ON (B)(6) 2024. THE PATIENT RETURNED WITH ADHESIONS AND A BOWEL OBSTRUCTION ON APPROXIMATELY ON (B)(6) 2024 AND THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559872 OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH FTM AROA BIOSURGERY F10246-2530P ERT-22L18 09421904065727

    Patients

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