BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ PERICARDIAL BIOPROSTHESIS - (AORTIC)

    MDR report key: 1896803 · Received November 11, 2010

    Report

    Report Number
    2015691-2010-14350
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    March 11, 2008
    Report Date
    October 14, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)=PLEURAL EFFUSION.DEVICE NOT RETURNED DUE TO DEVICE REMAINS IMPLANTED IN THE PATIENT.THE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER AND SERIAL NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    CLINICAL STUDY, (B)(4). THE FOLLOWING WAS REPORTED BY CLINICAL VIA EMAIL, PATIENT HAD A PLEURAL EFFUSION NECESSITATING A PLEURAL TAP ON (B)(6) 2008. POSSIBLE DEVICE RELATION TO EVENT, HOWEVER, THE OUTCOME WAS RESOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ PERICARDIAL BIOPROSTHESIS - (AORTIC) REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention