BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED BIOSCAFFOLD

    MDR report key: 8683048 · Received June 10, 2019

    Report

    Report Number
    3007321028-2019-00006
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    May 15, 2019
    Report Date
    June 10, 2019
    Manufacturer
    AROA BIOSURGERY
    Product Code
    FTM
    UDI-DI
    09421904065192
    PMA / PMN Number
    K153632
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE REPEATED REQUESTS, NO FURTHER DETAILS ON THE CAUSE, LOCATION, OR CONTENT OF THE ABSCESS WERE OBTAINED, NOR ANY FURTHER INFORMATION REGARDING THE FINDINGS DURING THE SECOND SURGERY. ABSENT FURTHER INFORMATION, NO CONCLUSIONS CAN BE DRAWN. BASED ON DOCUMENTED EXPERIENCE WITH POST-OPERATIVE INFECTIONS IT IS UNLIKELY THAT THE ABSCESS 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 THE EVENT. TELA BIO (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AROA BIOSURGERY (MANUFACTURER) VIA EXEMPTION NUMBER E2017045.

    Description of Event or Problem · 0

    A VENTRAL HERNIA REPAIR WAS PERFORMED WITH OVITEX 2S P ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ABSCESS A FEW WEEKS AFTER SURGERY WHICH DID NOT RESOLVE WITH PERCUTANEOUS DRAINS. THE PATIENT UNDERWENT A SECOND SURGERY ON APPROXIMATELY (B)(6) 2019 IN WHICH THE IMPLANT WAS FOUND PARTIALLY DIGESTED. THE SURGEON REMOVED THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476345 OVITEX REINFORCED BIOSCAFFOLD SURGICAL MESH FTM AROA BIOSURGERY ERT-8A07 09421904065192

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O