BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOTOFIX PATCH - 6CM X 8CM

    MDR report key: 12583083 · Received October 6, 2021

    Report

    Report Number
    1063481-2021-00029
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    July 25, 2021
    Report Date
    November 2, 2021
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    PSQ
    UDI-DI
    00877234000621
    PMA / PMN Number
    K183635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CRYOLIFE SALES REPRESENTATIVE RELAYED THAT PHOTOFIX WAS EXPLANTED FROM THE PATIENT ON (B)(6) 2021. THE PHOTOFIX WAS EXPLANTED DUE TO IT PULLING AWAY FROM THE SUTURE LINE AT THE VALVE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE GONE UNMET.

    Description of Event or Problem · 1

    CRYOLIFE SALES REPRESENTATIVE RELAYED THAT PHOTOFIX WAS EXPLANTED FROM THE PATIENT ON (B)(6) 2021. THE PHOTOFIX WAS EXPLANTED DUE TO IT PULLING AWAY FROM THE SUTURE LINE AT THE VALVE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE GONE UNMET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480314 PHOTOFIX PATCH - 6CM X 8CM INTRACARDIAC PATCH OR PLEDGET, BIOLOGICALLY DERIVED PSQ CRYOLIFE, INC. PFP 6X 12091020 00877234000621

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Other