BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOCEL

    MDR report key: 10782288 · Received November 3, 2020

    Report

    Report Number
    3012664855-2020-00005
    Event Type
    Injury
    Date Received
    November 3, 2020
    Manufacturer
    ADMEDUS REGEN PTY LTD
    Product Code
    DXZ
    PMA / PMN Number
    K130872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PEEL FORMATION DUE TO EXCESSIVE NEOINTIMA FORMATION, EXCESSIVE ADVENTITIAL RESPONSE AND STRUCTURAL DISRUPTION OF THE PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241544 CARDIOCEL INTRACARDIAC PATCH DXZ ADMEDUS REGEN PTY LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention