BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANGAROO ENVELOPE

    MDR report key: 23016691 · Received September 10, 2025

    Report

    Report Number
    3005619880-2025-00010
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    August 8, 2025
    Report Date
    September 10, 2025
    Manufacturer
    ELUTIA INC.
    Product Code
    FTM
    PMA / PMN Number
    K201313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE WAS RETURNED FOR EVALUATION. IT IS NOTED THAT PER THE INSTRUCTIONS FOR USE (IFU - ART-20662C) PROVIDED WITH THE FINISHED CANGAROO ENVELOPE DEVICE, INFLAMMATION IS LISTED AS A POTENTIAL COMPLICATION ASSOCIATED WITH THIS PROCEDURE AND DEVICE USAGE. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME, SHOULD ELUTIA RECEIVE ANY ADDITIONAL DETAILS RELATED TO THIS EVENT, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    A PATIENT ADVERSE EVENT WAS REPORTED BY AN ELUTIA REPRESENTATIVE ON 08/11/2025. THE PATIENT WAS IMPLANTED WITH A CANGAROO (LOT AND CATALOG NUMBER UNKNOWN) DEVICE IN (B)(6) 2025 (EXACT DATE WAS UNKNOWN); THIS WAS A DEVICE CHANGE OUT / REVISION FOR THE PATIENTS CARDIAC ELECTRONIC DEVICE. IT WAS REPORTED THAT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DUE TO WHAT THE PHYSICIAN THOUGHT WAS A HEMATOMA. UPON INTERVENTION, THE PHYSICIAN CONFIRMED THAT THERE WAS NOT A HEMATOMA, HOWEVER THE PATIENT DID HAVE INFLAMMATION. THE INFLAMED SITE WAS SWABBED FOR INFECTION (NO RESULTS HAVE BEEN GIVEN). AFTER TWO ATEMPTS TO GATHER ADDITIONAL DETAILS FROM THE PHYSICIAN, NO FURTHER INFORMATION REGARDING THIS EVENT IS KNOWN. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED ABOUT THE REPORTED EVENT A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751109 CANGAROO ENVELOPE MESH, SURGICAL FTM ELUTIA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other