BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIGIS-R LARGE

    MDR report key: 6008281 · Received October 6, 2016

    Report

    Report Number
    3005619263-2016-00042
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    July 20, 2016
    Report Date
    July 20, 2016
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH GRAM POSITIVE STAPHYLOCOCCUS AUREUS BACTEREMIA. THE PATIENT'S DEVICE SYSTEM WAS EXPLANTED, HOWEVER THE ABSORBABLE ENVELOPE HAD ALREADY BEEN ABSORBED AND WAS NO LONGER PRESENT. THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654964 AIGIS-R LARGE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6133 16C16711

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ICD