BEUDAMED
    FDA Adverse Event Death Summary report: N

    9 FRENCH BALLOON CATHETER 30CC

    MDR report key: 33461 · Received May 7, 1996

    Report

    Report Number
    33461
    Event Type
    Death
    Date Received
    May 7, 1996
    Date of Event
    April 30, 1996
    Report Date
    May 2, 1996
    Manufacturer
    C.R. BARD, INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD AN ANGIOPLASTY 4/29/96. ON 4/30/96, THE BALLOON DEVELOPED A LEAK AND HAD TO BE REMOVED. THE PT EXPIRED A SHORT TIME LATER. MAY HAVE BEEN UNRELATED TO EVENT. PT WAS DNR AND HAD A LIVING WILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9 FRENCH BALLOON CATHETER 30CC Implant BALLOON CATHETER DSP C.R. BARD, INC. CU6122

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death