BEUDAMED
    FDA Adverse Event Other Summary report: N

    TYRX BRAND AIGISRX R ANTIBACTERIAL ENVELOPE SM

    MDR report key: 3669615 · Received February 11, 2014

    Report

    Report Number
    3005619263-2014-00001
    Event Type
    Other
    Date Received
    February 11, 2014
    Date of Event
    October 29, 2013
    Report Date
    January 13, 2013
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR HAS NO INFO FURTHER THAN THAT THE DEVICE WAS IMPLANTED AND PT PRESENTED WITH HEMATOMA AT THE IMPLANT SITE. DEVICE AS EXPLANTED ON (B)(6)2013. THERE IS NO FURTHER INFO ON THE PT OR THE EVENT. HEMATOMA IS AN EXPECTED COMPLICATION OF IED IMPLANT WITH OR WITHOUT IMPLANTATION OF AN AIGISRX R ENVELOPE.

    Description of Event or Problem · 1

    PT PRESENTED WITH HEMATOMA IN IMPLANT SITE. BLOOD CULTURE ON (B)(6) 2013 RESULTS IN STAPH HOMINIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88867 TYRX BRAND AIGISRX R ANTIBACTERIAL ENVELOPE SM AIGISRX R ANTIBACTERIAL ENVELOPE FTL TYRX, INC. CMRM 6122US-S 13H22368

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR Hospitalization