BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUPRO ANTIBIOTIC-ELUTING BIO-ENVELOPE

    MDR report key: 24090377 · Received January 15, 2026

    Report

    Report Number
    3005619880-2026-50001
    Event Type
    Injury
    Date Received
    January 15, 2026
    Date of Event
    December 18, 2025
    Report Date
    January 15, 2026
    Manufacturer
    ELUTIA INC.
    Product Code
    FTM
    PMA / PMN Number
    K233991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS NOTED THAT PER THE INSTRUCTIONS FOR USE (IFU -ART-20837 REV. A, IFU ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE) PROVIDED WITH THE FINISHED ELUPRO DEVICE, "INFECTION" IS LISTED WITHIN THE POTENTIAL COMPLICATIONS ASSOCIATED WITH DEVICE USAGE. INFECTION IS A KNOWN COMPLICATION WITH THE IMPLANT OF A CARDIAC IMPLANTABLE DEVICE.

    Description of Event or Problem · 0

    A PHONE CALL WAS RECEIVED ON DECEMBER 18, 2025 FROM A BOSTON SCIENTIFIC REPRESENTATIVE THAT A PATIENT WHO WAS IMPLANTED WITH AN ELUPRO DEVICE (PART AND LOT NUMBER UNKNOWN) BY DR. WHALEN AT WAKE FOREST BAPTIST. THE PATIENT LATER HAD AN INFECTION ACCORDING TO THE PHYSICIAN. NO FURTHER DETAILS ARE AVAILABLE REGARDING THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151422 ELUPRO ANTIBIOTIC-ELUTING BIO-ENVELOPE CANGAROO RM ANTIBACTERIAL ENVELOPE FTM ELUTIA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other