BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWP CATHETER

    MDR report key: 52404 · Received November 19, 1996

    Report

    Report Number
    1217435-1996-00110
    Event Type
    Malfunction
    Date Received
    November 19, 1996
    Date of Event
    October 21, 1996
    Report Date
    October 23, 1996
    Manufacturer
    USCI DIV. C.R. BARD, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PREP THE BALLOON OF THIS DEVICE RUPTURED. THERE WAS NO PT INVOLVEMENT. THE DEVICE IS NOT BEING RETURNED FOR CO' ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PWP CATHETER BALLOON CATHETER DQO USCI DIV. C.R. BARD, INC. NA 08JF1036

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR