BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 117868 · Received September 3, 1997

    Report

    Report Number
    6000002-1997-00705
    Event Type
    Injury
    Date Received
    September 3, 1997
    Date of Event
    July 28, 1997
    Report Date
    August 4, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP./EDWARDS CVS DIVISION
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SUBSEQUENTLY TO CO'S REPORT SUBMITTED ON OCTOBER 15, 1997, CO HAS REC'D ADD'L INFO INDICATING THAT THIS EVENT WAS NON DEVICE RELATED. PLEASE REMOVE THIS REPORT FROM YOUR DATABASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention
    2