BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED TISSUE MATRIX

    MDR report key: 18798391 · Received February 28, 2024

    Report

    Report Number
    3010513348-2024-00005
    Event Type
    Injury
    Date Received
    February 28, 2024
    Date of Event
    February 13, 2024
    Report Date
    February 28, 2024
    Manufacturer
    AROA BIOSURGERY
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT 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.

    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 (B)(6) 2023 WITH A SEROMA. THIS WAS DRAINED UNDER IR A DRAIN PLACED IN (B)(6) 2023 WITH THE DRAIN REMOVED 3 WEEKS LATER. ON (B)(6) 2024 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
    497855 OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH FTM AROA BIOSURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Hospitalization| R