BEUDAMED
    FDA Adverse Event Other Summary report: N

    EDI CATHETER

    MDR report key: 2202221 · Received August 5, 2011

    Report

    Report Number
    MW5021684
    Event Type
    Other
    Date Received
    August 5, 2011
    Date of Event
    July 14, 2011
    Report Date
    August 5, 2011
    Manufacturer
    MAQUET
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    (B)(6) INFANT WITH RDS, RECEIVED NAVA VENTILATOR SUPPORT. EDI CATHETER IN USE (B)(6) 2011-(B)(6) 2011. THIS (B)(6) INFANT TREATED WITH NAVA AND NIV NAVA SUPPORT FROM DAY 3 OF LIFE UNTIL DAY 12. AT (B)(6) OF AGE INFANT AFTER A SIGNIFICANT CHOKING EPISODE NOTED TO HAVE AN ESOPHAGEAL STRICTURE PER UGI. REPORT MADE AT REQUEST OF PHYSICIAN DUE TO PREVIOUS USE OF EDI CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDI CATHETER NAVA CATHETER CBK MAQUET 92039889

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Other