BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED TISSUE MATRIX

    MDR report key: 18880290 · Received March 11, 2024

    Report

    Report Number
    3007321028-2023-00044
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    February 13, 2024
    Report Date
    March 4, 2024
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE DATE OF IMPLANT IS APPROXIMATE TO THE MONTH OF IMPLANT REPORTED BY THE PHYSICIAN. IT CANNOT BE DETERMINED WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT NOTED. SEROMA, INFECTION, AND REOPERATION ARE KNOWN ADVERSE EVENTS AND POTENTIAL OUTCOMES ASSOCIATED WITH HERNIA REPAIR SURGERY AS NOTED IN THE DEVICE'S INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT IPOM REPAIR WITH OVITEX 2S IN APPROXIMATELY (B)(6) 2023 RETURNED IN DECEMBER 2023 WITH A SEROMA. THIS WAS DRAINED UNDER IR A DRAIN PLACED IN DECEMBER 2023 WITH THE DRAIN REMOVED 3 WEEKS LATER. ON 13FEB24 IT WAS REPORTED THAT THE SEROMA CONTINUED AND APPEARED TO HAVE BECOME INFECTED AND THE DEVICE WAS TO BE EXPLANTED THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1967293 OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH, PRODUCT CODE: FTM FTM AROA BIOSURGERY LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention| O| H| L