BEUDAMED
    FDA Adverse Event Other Summary report: N

    TYRX AIGIS

    MDR report key: 3070212 · Received April 17, 2013

    Report

    Report Number
    3005619263-2012-00006
    Event Type
    Other
    Date Received
    April 17, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    063091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED DUE TO A SUSPECTED ADVERSE REACTION TO RIFAMPIN AND/ OR MINOCYCLINE. PATIENT HAS A HISTORY OF ALLERGIES, INCLUDING ALLERGIES TO TAPE ADHESIVE WHICH RESULTED IN SKIN BLISTERS. THE AIGIS IFU IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF ALLERGY TO RIFAMPIN, TETRACYCLINES, OR POLYPROPYLENE. THE DEVICE WAS NOT RETURNED FOR EVALUATION AFTER EXPLANTATION, BECAUSE NEITHER CUSTOMER NOR TYRX COULD STERILIZE THE DEVICE AFTER EXPLANTATION. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PATIENT RECOVERED FULLY.

    Description of Event or Problem · 1

    (B)(6) - GENERATOR CHANGE. (B)(6) - POCKET REVISION W AIGIS, HEMATOMA EVAC, POUCH IMPLANTED. (B)(6) - YELLOW DRAINAGE EVACUATED POUCH REMOVED FOR SUSPECTED ALLERGY TO TETRACYCLINE AND RIFAMPIN. PATIENT HAD MULTIPLE ALLERGIES INCLUDING ALLERGIES TO THE TAPE ADHESIVE RESULTING IN SKIN BLISTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165006 TYRX AIGIS ANTIBACTERIAL ENVELOPE FTL TYRX, INC. CMRM31335 12G23291 OR 12H1429

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization BOSTON SCIENTIFIC ICD E162