BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOCEL

    MDR report key: 10782210 · Received November 3, 2020

    Report

    Report Number
    3012664855-2020-00001
    Event Type
    Injury
    Date Received
    November 3, 2020
    Date of Event
    September 13, 2014
    Manufacturer
    ADMEDUS REGEN PTY LTD
    Product Code
    DXZ
    PMA / PMN Number
    K130872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DIAGNOSIS SDD. DORV WITH SUB-PULMONARY INTERVENTRICULAR DEFET HYPOPLASIA AORTIC ARCH.

    Description of Event or Problem · 1

    RECOARCTATION OF THE AORTA DUE TO THE THICKNESS OF THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241512 CARDIOCEL INTRACARDIAC PATCH DXZ ADMEDUS REGEN PTY LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention