BEUDAMED
    FDA Adverse Event Other Summary report: N

    TYRX BRAND AIGISRX R ANTIBACTERIAL ENVELOPE LG

    MDR report key: 3669617 · Received February 11, 2014

    Report

    Report Number
    3005619263-2014-00002
    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 LETHARGY. DEVICE WAS EXPLANTED ON (B)(6) 2013. THERE IS NO FURTHER INFO ON THE PT OR THE EVENT.

    Description of Event or Problem · 1

    PT PRESENTED WITH LETHARGY. BLOOD CULTURE ON (B)(6) 2013 RESULTS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89007 TYRX BRAND AIGISRX R ANTIBACTERIAL ENVELOPE LG AIGISRX R ANTIBACTERIAL ENVELOPE FTL TYRX, INC. CMRM 6122US-S 13H02363

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization