BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER EDWARDS PHYSIO RING

    MDR report key: 144740 · Received January 15, 1998

    Report

    Report Number
    6000002-1998-00002
    Event Type
    Death
    Date Received
    January 15, 1998
    Date of Event
    March 29, 1997
    Report Date
    December 16, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE FOLLOW-UP TELEPHONE CALL FOR A MARKETING STUDY FOR THIS DEVICE, IT WAS LEARNED THAT THE PT EXPIRED AT A CONVALESCENT HOSP ON MARCH 29, 1997 DUE TO CONGESTIVE HEART FAILURE, DIABETES MELLITUS AND HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER EDWARDS PHYSIO RING Implant ANNULOPLASTY RING KRH BAXTER HEALTHCARE CORP. 4450 4D0491

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death