BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALADDIN INFANT FLOW SYSTEM

    MDR report key: 49886 · Received November 14, 1996

    Report

    Report Number
    2937708-1996-90001
    Event Type
    Injury
    Date Received
    November 14, 1996
    Date of Event
    September 27, 1996
    Report Date
    October 17, 1996
    Manufacturer
    HAMILTON MEDICAL, INC.
    Product Code
    CAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS USING THE INFANT FLOW SYSTEM AS PART OF THE RESPIRATORY SYSTEM, AND DEVELOPED A PRESSUE INJURY TO THE NASAL SEPTUM /NARES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALADDIN INFANT FLOW SYSTEM NASAL CANNULA CAT HAMILTON MEDICAL, INC. * 960306

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Required Intervention ORAL/GASTRIC TUBE, FR5| MODEL