BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIGIS-R MEDIUM

    MDR report key: 7893094 · Received September 20, 2018

    Report

    Report Number
    3005619263-2018-00083
    Event Type
    Malfunction
    Date Received
    September 20, 2018
    Date of Event
    September 13, 2018
    Report Date
    September 20, 2018
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MANUFACTURED DATE AND THE EXPIRATION DATE ON THE PACKAGING OF THE ABSORBABLE ANTIBACTERIAL ENVELOPE WERE INCORRECT BECAUSE THE DATES WERE SWITCHED WITH ONE ANOTHER. THE PRODUCTS WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733943 AIGIS-R MEDIUM MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6122CA 18F18051

    Patients

    Seq Age Sex Outcome Treatment
    1