BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED TISSUE MATRIX

    MDR report key: 19048761 · Received April 5, 2024

    Report

    Report Number
    3007321028-2024-00021
    Event Type
    Injury
    Date Received
    April 5, 2024
    Date of Event
    March 7, 2024
    Report Date
    April 4, 2024
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    FTM
    UDI-DI
    00942190465703
    PMA / PMN Number
    K181935
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN WHETHER THE WOUND ISSUE NOTED CAUSED OR CONTRIBUTED TO THE STATE OF THE OVITEX DEVICE SEEN AT REOPERATION. IT IS POSSIBLE GIVEN THE COMPLEX NATURE OF THE CASE THAT THE DEVICE DID NOT INTEGRATE PROPERLY AND WAS PARTIALLY BROKEN DOWN FOLLOWING THE INITIAL REPAIR SURGERY. AROA'S REVIEW OF MANUFACTURING DOCUMENTATION FOR THE SUBJECT LOT (ERT-22D01) HAS CONFIRMED THAT THE DEVICES WERE PRODUCED IN ACCORDANCE WITH THE ESTABLISHED MANUFACTURING PROCEDURES, WITH ALL PROCESS SPECIFICATIONS AND FINAL RELEASE SPECIFICATIONS SATISFIED.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT A HERNIA REPAIR WHERE A SANDWICH TECHNIQUE WAS UTILIZED, INVOLVING THE PLACEMENT OF OVITEX 2S INTRAABDOMINALLY AS A PARTIAL BRIDGE. ADDITIONALLY, A PIECE OF OVITEX CORE WAS PLACED ANTERIORLY ON THE FASCIA. APPROXIMATELY THREE MONTHS POST-SURGERY, THE PATIENT EXPERIENCED A NON-HEALING WOUND NECESSITATING A REOPERATION. DURING THIS SUBSEQUENT PROCEDURE, THE SURGEON DISCOVERED SOME UNINCORPORATED POLYMERIC ELEMENTS OF THE OVITEX OVERLAY PIECE. DESPITE THIS, THE PARTIALLY BRIDGED OVITEX 2S REMAINED INTACT AND CONTINUED TO EFFECTIVELY MAINTAIN THE INTEGRITY OF THE HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2267622 OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH FTM AROA BIOSURGERY LTD. F10244-2530P ERT-22D01 00942190465703

    Patients

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