BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM (RECTANGLE) PFP6X8 6 CM X 8 CM

    MDR report key: 11651652 · Received April 12, 2021

    Report

    Report Number
    1063481-2021-00016
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    March 26, 2020
    Report Date
    June 2, 2021
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    PSQ
    PMA / PMN Number
    K183635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORT RECEIVED, A PUBLICATION REPORTED "RECURRENT FIBROVASCULAR GRANULATION ON PHOTOFIX BOVINE PERICARDIUM CAUSING SYSTEMIC AND PULMONARY VENOUS OBSTRUCTION AFTER REPAIR OF SCIMITAR SYNDROME. NP TAYLOR, Z LONG, A ARUNAMATA, M MA - CARDIOLOGY IN THE YOUNG, 2021 HTTPS://WWW.CAMBRIDGE.ORG/CORE/JOURNALS/CARDIOLOGY-IN-THE-YOUNG/ARTICLE/ABS/RECURRENT-FIBROVASCULAR-GRANULATION-ON-PHOTOFIX-BOVINE-PERICARDIUM-CAUSING-SYSTEMIC-AND-PULMONARY-VENOUS-OBSTRUCTION-AFTER-REPAIR-OF-SCIMITAR-SYNDROME/A7FE7A2A17F9A8F203232BDBA1605A47".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548025 PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM (RECTANGLE) PFP6X8 6 CM X 8 CM PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM PSQ CRYOLIFE, INC. PFP6X8 11062618

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| O