BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGIS

    MDR report key: 6164034 · Received December 9, 2016

    Report

    Report Number
    3005619263-2016-00052
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    October 23, 2016
    Report Date
    October 24, 2016
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K150291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED A STAPHYLOCOCCUS INFECTION AFTER APPLICATION OF THE ABSORB-ABLE ANTIBACTERIAL ENVELOPE. THE ASSOCIATED PRODUCTS WERE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809057 AIGIS MESH, SURGICAL, POLYMERIC FTL TYRX, INC. NMR6133 16H15753

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R 97714 IPG, 977A260 LEAD, 977A260 LEAD