BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIGISRX ST ANTIBACTERIAL SOFT TISSUE REPAIR

    MDR report key: 3250513 · Received July 1, 2013

    Report

    Report Number
    3005619263-2013-00004
    Event Type
    Other
    Date Received
    July 1, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    TYRX INC
    Product Code
    FTL
    PMA / PMN Number
    K093524
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT OF A SUSPECTED ALLERGIC REACTION TO THE RIFAMPIN COATED ON THE SURGICAL MESH DEVICE. THE DEVICE WAS IMPLANTED ON (B)(6) 2013 EXPLANTED ON THE SAME DAY. THE AIGIS DEVICE WAS IMPLANTED SUB MUSCULAR ALONG WITH A NEW DEVICE (TYPE UNK). THE PT HAD A PREVIOUS INFECTION. PT DEVELOPED A SUSPECTED ADVERSE REACTION TO RIFAMPIN. IMPLANTATION OF AIGIS INTO AN INFECTED WOUND IS NOT RECOMMENDED. ALLERGIC REACTIONS TO ANTIBIOTICS ARE NOT UNEXPECTED. THERE IS NO OUTCOME INFO FOR THIS PT AND THIS EVENT. FOLLOW-UP REPORTS WILL BE SUBMITTED WHEN ADDITIONAL INFO IS RECEIVED.

    Description of Event or Problem · 1

    THE INITIAL IMPLANT WAS DONE ON (B)(6) AND THE EXPLANT WAS DONE ON (B)(6). THE REACTION WAS SYSTEMIC AND AIGIS WAS PLACED SUB MUSCULAR ALONG WITH THE NEW DEVICE ON THE (B)(6). PT ALSO WAS ITCHING AT SITE OF POST OP ON THE (B)(6). PT HAD NO HISTORY OF ALLERGIES TO EITHER THE MINOCYCLINE OR RIFAMPIN. PT WAS GIVEN MINOCYCLINE POST OP ON THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299827 AIGISRX ST ANTIBACTERIAL SOFT TISSUE REPAIR AIGISRX ST FTL TYRX INC STRD3136 12M11317

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization ZYVOX POST OPERATIVELY| MINOCYCLINE POST OPERATIVELY