BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 4439467 · Received January 21, 2015

    Report

    Report Number
    3004478276-2014-00080
    Event Type
    Injury
    Date Received
    January 21, 2015
    Date of Event
    December 19, 2014
    Report Date
    January 21, 2015
    Manufacturer
    SORIN GROUP CANADA INC.
    Product Code
    DYE
    PMA / PMN Number
    P060038/S002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE WAS NOT RETURNED AND NO SERIAL NUMBER WAS PROVIDED, NO INVESTIGATION WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    RESULTS: REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED UPON IDENTIFICATION OF THE VALVE SERIAL NUMBER. HISTOPATHOLOGICAL EVALUATION WILL BE PERFORMED, IF DEVICE IS RETURNED.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON (B)(4) 2014 THAT MITROFLOW VALVE (MODEL LXA, SIZE AND SERIAL # -UNKNOWN) WAS EXPLANTED ON (B)(6) 2014. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2014 THAT MITROFLOW VALVE (MODEL LXA, SIZE AND SERIAL # -UNKNOWN) WAS EXPLANTED ON (B)(6) 2014. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50374 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE HEART VALVE DYE SORIN GROUP CANADA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention