BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED TISSUE MATRIX

    MDR report key: 12595175 · Received October 7, 2021

    Report

    Report Number
    3007321028-2021-00013
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    October 2, 2020
    Report Date
    October 8, 2021
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    FTM
    UDI-DI
    09421904065116
    PMA / PMN Number
    K153633
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF MANUFACTURING RECORDS DID NOT RESULT IN ANY INDICATION OF A DEVICE PROBLEM.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT VENTRAL HERNIA REPAIR WITH OVITEX 1SP ON (B)(6) 2018. THE PATIENT DEVELOPED PERSISTENT INFECTION AND WOUND DEHISCENCE WITH PRESENCE OF SEROMA. SURGICAL INTERVENTION WAS CONDUCTED ON (B)(6) 2020 INCLUDING DEBRIDEMENT OF ABDOMINAL WALL SKIN/SINUS TRACT AND REMOVAL OF EMBEDDED REPAIR MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485461 OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH FTM AROA BIOSURGERY LTD. F10246-1620P ERT-6I10 09421904065116

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R