BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGIS-R MEDIUM

    MDR report key: 6006847 · Received October 6, 2016

    Report

    Report Number
    3005619263-2016-00040
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    July 12, 2016
    Report Date
    July 12, 2016
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 AN INFECTION. THE ORGANISM RESPONSIBLE WAS PSEUDOMONAS. THE ABSORBABLE ANTIBACTERIAL ENVELOPE IS NO LONGER IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656749 AIGIS-R MEDIUM MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6122 16D05717

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R LNQ11 ICM