BEUDAMED
    FDA Adverse Event Death Summary report: N

    TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE

    MDR report key: 14316316 · Received May 7, 2022

    Report

    Report Number
    3005619263-2022-00008
    Event Type
    Death
    Date Received
    May 7, 2022
    Date of Event
    April 6, 2022
    Report Date
    May 6, 2022
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCTS: DTMA1D4 CRT-D IMPLANTED: (B)(6) 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT, WHO HAS A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS ADMITTED TO A HOSPITAL DUE TO SEPSIS. TWO DAYS AFTER THE PATIENT WAS ADMITTED, THE PATIENT PASSED AWAY. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. IT WAS NOTED THAT THE CRT-D WAS IMPLANTED WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516566 TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE MESH, SURGICAL, POLYMERIC FTL TYRX, INC. TYRX-AAE

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Male Death 429688 LEAD, 6935M62 LEAD, 5076-52 LEAD