BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED BIOSCAFFOLD

    MDR report key: 10148826 · Received June 12, 2020

    Report

    Report Number
    3010513348-2020-00003
    Event Type
    Injury
    Date Received
    June 12, 2020
    Date of Event
    May 20, 2020
    Report Date
    June 12, 2020
    Manufacturer
    AROA BIOSURGERY
    Product Code
    FTM
    UDI-DI
    09421904065093
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GIVEN THE CULTURE RESULTS, IT IS LIKELY THAT THE BACTERIA ORIGINATED FROM BOTH THE ISCHEMIC BOWEL AND THE SKIN.

    Description of Event or Problem · 1

    OVITEX 1SP WAS USED TO ROBOTICALLY REPAIR AN UMBILICAL HERNIA CONTAINING TWO BOWEL LOOPS, ONE OF WHICH WAS INCARCERATED CAUSING BOWEL OBSTRUCTION AND BOWEL ISCHEMIA. THE DEVICE WAS INTRODUCED THROUGH THE INCISION SITE. APPROXIMATELY ONE WEEK LATER, THE WOUND BECAME RED AND AN ABSCESS FORMED BETWEEN THE OVITEX AND THE ABDOMINAL WALL. THE SURGEON STARTED ANTIBIOTICS, INCISED THE ABSCESS AND REMOVED THE DEVICE. CULTURES WERE POSITIVE FOR E. COLI AND STREPTOCOCCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611271 OVITEX REINFORCED BIOSCAFFOLD SURGICAL MESH FTM AROA BIOSURGERY F10246-1012P ERT-9A06 09421904065093

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R