BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAIM-TURI CATHETER

    MDR report key: 93591 · Received May 22, 1997

    Report

    Report Number
    1217435-1997-00165
    Event Type
    Malfunction
    Date Received
    May 22, 1997
    Date of Event
    April 22, 1997
    Report Date
    April 25, 1997
    Manufacturer
    USCI DIV C.R. BARD, INC.
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BALLOON OF THIS DEVICE RUPTURED DURING PREP THERE WAS NO PT INVOLVEMENT. THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAIM-TURI CATHETER Implant MONITOR/PACING CATHETER DRF USCI DIV C.R. BARD, INC. NA 08CG0033

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN