BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED BIOSCAFFOLD

    MDR report key: 8574797 · Received May 2, 2019

    Report

    Report Number
    3007321028-2019-00005
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    April 3, 2019
    Report Date
    May 2, 2019
    Manufacturer
    AROA BIOSURGERY
    Product Code
    FTM
    UDI-DI
    09421904065734
    PMA / PMN Number
    K181935
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS LIKELY THAT THE BILE LEAK AND INFECTION CAUSED THE PARTIAL DIGESTION OF THE IMPLANT. A DHR REVIEW WAS COMPLETED AND NO NON-CONFORMANCES OR ANOMALIES WERE FOUND THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    A PATIENT TREATED FOR A VENTRAL HERNIA WITH OVITEX 1S P ON (B)(6) 2019 UNDERWENT A REOPERATION ON (B)(6) 2019. DURING THE REOPERATION, A BILE LEAK AND AN INFECTION WERE NOTED. THE OVINE PORTION OF THE OVITEX MESH HAD BEEN PARTIALLY DIGESTED. THE IMPLANT WAS REMOVED; THE WOUND WAS LEFT OPEN AND TREATED WITH NEGATIVE WOUND PRESSURE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365409 OVITEX REINFORCED BIOSCAFFOLD SURGICAL MESH FTM AROA BIOSURGERY ERT-8I06 09421904065734

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O