BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED TISSUE MATRIX

    MDR report key: 12533783 · Received September 27, 2021

    Report

    Report Number
    3010513348-2021-00005
    Event Type
    Injury
    Date Received
    September 27, 2021
    Date of Event
    March 25, 2019
    Report Date
    September 27, 2021
    Manufacturer
    AROA BIOSURGERY
    Product Code
    FTM
    UDI-DI
    09421904065130
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS LIKELY THAT THE FISTULA FORMED SECONDARY TO A SURGICAL ERROR IN THE INITIAL PROCEDURE SUCH AS A SMALL BOWL PERFORATION. THIS WOULD LEAD TO FISTULA FORMATION, ABSCESS, AND GROSS INFLAMMATION ACCOUNTING FOR THE NOTED EXTENSIVE ADHESIONS. GIVEN THE SHORT TIME FRAME BETWEEN INITIAL SURGERY AND THE EVENTS NOTED (APPROXIMATELY 1 MONTH), IT IS HIGHLY UNLIKELY THAT THE DEVICE WOULD HAVE CAUSED OR CONTRIBUTED TO THESE EVENTS. WHILE IT IS UNLIKELY THAT THE DEVICE IS THE INITIATING CAUSE OF THE ABSCESS AND FISTULA, ITS PRESENCE MAY HAVE BEEN A FACTOR IN THE INFLAMMATORY RESPONSE AND SUBSEQUENT REMOVAL.

    Description of Event or Problem · 1

    AFTER VENTRAL HERNIA REPAIR WITH OVITEX 1SP ON (B)(6) 2019, A PATIENT PRESENTED WITH GENERAL MALAISE AND FEVER. SHE PRESENTED WITH AN ABDOMINAL WALL ABSCESS AND SMALL BOWEL FISTULA ON (B)(6) 2019 WITH SURGERY TO RESOLVE. A PORTION OF THE DEVICE WAS REMOVED. PART OF THE DEVICE WAS ADHERENT TO THE SMALL BOWEL AND REMAINED IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432649 OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH FTM AROA BIOSURGERY F10246-2020P ERT-7J01 09421904065130

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R