BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARPENTIER-EDWARDS BIOPROSTHESIS

    MDR report key: 116523 · Received August 22, 1997

    Report

    Report Number
    6000002-1997-00691
    Event Type
    Other
    Date Received
    August 22, 1997
    Date of Event
    July 23, 1997
    Report Date
    July 24, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP. EDWARDS CVS DIV.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED AS SURGICAL INTERVENTION AT IMPLANT FOR A PARAVALVULAR LEAK. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS BIOPROSTHESIS Implant REPLACEMENT HEART VALVE LWR BAXTER HEALTHCARE CORP. EDWARDS CVS DIV. 6625 7C0224

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention