BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGIS-R LARGE

    MDR report key: 6007342 · Received October 6, 2016

    Report

    Report Number
    3005619263-2016-00044
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    July 17, 2016
    Report Date
    September 27, 2016
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    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 THAT THE PATIENT WAS SEEN IN THE CLINIC DUE TO AN OPENING AT THE DEVICE SITE APPROXIMATELY TWO MONTHS POST IMPLANT OF THE ANTIBACTERIAL ENVELOPE . IT WAS FURTHER REPORTED THE PATIENT OBSERVED PUS DRAINAGE. THE PATIENT WAS DIAGNOSED WITH A SUPERFICIAL INCISION INFECTION AND WAS TREATED WITH ORAL ANTIBIOTICS. THE PATIENT IS A PARTICIPANT IN THE WRAP-IT CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655905 AIGIS-R LARGE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6133CA 16B24703

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention DTBA2Q1 ICD, 693565 LEAD