BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

    MDR report key: 222457 · Received May 6, 1999

    Report

    Report Number
    6000002-1999-00122
    Event Type
    Injury
    Date Received
    May 6, 1999
    Date of Event
    December 7, 1998
    Report Date
    April 7, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED AS VEGETATION ON VALVE, ENDOCARDITIS WITH SEPTAL ABSCESS, FEVER AND CHILLS. PT WAS TREATED WITH IV ANTIBIOTICS FOR 1 WEEK PRIOR TO REOPERATION ON 12/07/1998. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS Implant REPLACEMENT HEART VALVE LWR BAXTER HEALTHCARE CORP. 2700 8E0553

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention IMPLANT OF COSGROVE-EDWARDS ANNULOPLASTY SYSTEM,| MODEL 4600 07/15/1998.