BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED TISSUE MATRIX

    MDR report key: 12611838 · Received October 11, 2021

    Report

    Report Number
    3007321028-2021-00014
    Event Type
    Injury
    Date Received
    October 11, 2021
    Date of Event
    March 25, 2019
    Report Date
    October 12, 2021
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    FTM
    UDI-DI
    09421904065130
    PMA / PMN Number
    K153633
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT OF MANUFACTURING INVESTIGATION DID NOT INDICATE ANY ISSUE WITH THE SUBJECT DEVICE.

    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
    1508701 OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH FTM AROA BIOSURGERY LTD. F10246-2020P ERT-7J01 09421904065130

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R