BEUDAMED
    FDA Adverse Event Summary report: N

    FOGARTY ARTERIAL CATHETER

    MDR report key: 10650 · Received December 23, 1993

    Report

    Report Number
    MW1000220
    Date Received
    December 23, 1993
    Report Date
    December 22, 1993
    Manufacturer
    EDWARDS DIV. BAXTER HEALTHCARE CORP.
    Product Code
    DXE
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RPTR STATES THAT THE CATHETER BALLOONS KEEP BREAKING. THE PROBLEM HAS OCCURRED WITH THREE DEVICES FROM CATALOQUE CV1042A AND ONE DEVICE FROM CATALOGUE CV1046A. (ALSO SEE 1000221.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL CATHETER DXE EDWARDS DIV. BAXTER HEALTHCARE CORP. 311-388-0058

    Patients

    Seq Age Sex Outcome Treatment
    1 *