BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIGIS-R LARGE

    MDR report key: 4161095 · Received October 10, 2014

    Report

    Report Number
    3005619263-2014-00008
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE SALES REPRESENTATIVE NOTICED THE PRODUCT WAS BEYOND ITS "USE-BEFORE-DATE." THE PHYSICIAN REQUESTED USE OF THE PRODUCT. THE PRODUCT WAS IMPLANTED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642533 AIGIS-R LARGE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6133 14E05451

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR