BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE

    MDR report key: 9146441 · Received October 2, 2019

    Report

    Report Number
    3005619263-2019-00031
    Event Type
    Injury
    Date Received
    October 2, 2019
    Report Date
    October 2, 2019
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 PATIENT WAS ADMITTED TO THE HOSPITAL WITH A POCKET INFECTION. THE PATIENT'S ANTIBACTERIAL ABSORBABLE ENVELOPE CURRENTLY REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939684 TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6122EU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other