BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS BIOPROSTHESIS

    MDR report key: 72519 · Received February 27, 1997

    Report

    Report Number
    6000002-1997-00175
    Event Type
    Injury
    Date Received
    February 27, 1997
    Date of Event
    December 17, 1996
    Report Date
    January 28, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SUBSEQUENTLY TO CO'S REPORT SUBMITTED ON OCTOBER 10, 1996, THIS MEDWATCH WAS INADVERTANTLY REPORTED. PLEASE REMOVE THIS REPORT FROM YOUR DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS BIOPROSTHESIS Implant REPLACEMENT HEART VALVE LWR BAXTER HEALTHCARE CORP. 6625 7K1525

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention