BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 287287 · Received July 28, 2000

    Report

    Report Number
    287287
    Event Type
    Death
    Date Received
    July 28, 2000
    Date of Event
    July 18, 2000
    Report Date
    July 28, 2000
    Manufacturer
    CORDIS CORP. JOHNSON & JOHNSON
    Product Code
    FCL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC CATHETERIZATION PROCEDURE, BIOPSY FORCEPS FAILED TO OPEN WHEN LEVER WAS PULLED. FINAL CAUSE OF DEATH NOT KNOWN AT THIS TIME, THOUGH PHYSICIAN RECEIVED VERBAL REPORT THAT RIGHT VENTRICLE WAS PERFORATED. PHYSICIAN FELT THAT PROBLEM EXPERIENCED WITH PRODUCT NOT OPENING WAS UNRELATED TO ADVERSE EVENT OUTCOME. BIOMEDICAL ENGINEERING RECEIVED OCCURRENCE REPORT 7/19/00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BIOPSY FORCEPS FCL CORDIS CORP. JOHNSON & JOHNSON * 70999260

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death