BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOCEL INTRACARDIAC PATCH

    MDR report key: 10782179 · Received November 3, 2020

    Report

    Report Number
    3012664855-2020-00012
    Event Type
    Injury
    Date Received
    November 3, 2020
    Report Date
    September 19, 2020
    Manufacturer
    ADMEDUS REGEN PTY LTD
    Product Code
    DXZ
    PMA / PMN Number
    K130872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DIAGNOSIS: HYPOPLASTIC ARCH IN CONJUNCTION WITH AN ATERIAL SWITCH. SIGNIFICANT RESTENOSIS OF THE ARCH AT 2-3 MONTH. ALL REPAIRED SUTURE LINES ON PULMONARY ARTERY AND AORTIC ARCH WERE ALL SUBJECTED TO EXAGGERATED GROWTH OF THE INTIMA, TO THE POINT OF STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241494 CARDIOCEL INTRACARDIAC PATCH INTRACARDIAC PATCH DXZ ADMEDUS REGEN PTY LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Required Intervention