BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE

    MDR report key: 11620342 · Received April 6, 2021

    Report

    Report Number
    3005619263-2021-00016
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    June 1, 2018
    Report Date
    April 6, 2021
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    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'S RIGHT ATRIAL (RA) LEAD, RIGHT VENTRICULAR (RV) LEAD AND ANTIBACTERIAL ABSORBABLE ENVELOPE EXPERIENCED DECUBITUS APPROXIMATELY SIX DAYS POST IMPLANT. IT WAS NOTED THAT THE LEADS WERE EXPLANTED AND THE ENVELOPE REMAINS IN USE. THE PATIENT UNDERWENT A POCKET REVISION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518258 TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6133EU 18C22025

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R 5076-52 LEAD, 5076-58 LEAD