BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED TISSUE MATRIX

    MDR report key: 12533761 · Received September 27, 2021

    Report

    Report Number
    3010513348-2021-00004
    Event Type
    Injury
    Date Received
    September 27, 2021
    Date of Event
    February 10, 2020
    Report Date
    September 29, 2021
    Manufacturer
    AROA BIOSURGERY
    Product Code
    FTM
    UDI-DI
    09421904065116
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT EXPERIENCED A PERSISTENT INFECTION, WOUND DEHISCENCE, AND RELATED EVENTS LEADING TO EVENTUAL DEVICE REMOVAL. AS THESE EVENTS WERE FIRST EXPERIENCED SUPERFICIALLY, IS UNLIKELY THAT THE IMPLANTED DEVICE WAS THE INITIATING CAUSE OF THESE EVENTS.

    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
    1432718 OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH FTM AROA BIOSURGERY F10246-1620P ERT-6I10 09421904065116

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R