BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTECH PRODUCTS LLC

    MDR report key: 6761019 · Received August 2, 2017

    Report

    Report Number
    2025917-2017-00103
    Event Type
    Injury
    Date Received
    August 2, 2017
    Report Date
    August 2, 2017
    Manufacturer
    NEOTECH PRODUCTS LLC
    Product Code
    CAT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED AND NO EVALUATION IS POSSIBLE ON THE ACTUAL DEVICE. HOWEVER RETAINED SAMPLES AND INSPECTION RECORDS OF LOT# 2016-0411 WERE REVIEWED AND NO FAILURE OR ABNORMALITY WAS FOUND ON PRODUCTS IN THE INVENTORY. MORE CONSCIOUSNESS OF HOSPITAL PERSONNEL TO THE DIRECTION FOR USE (DFU) COULD PREVENT THIS INCIDENT: -IMPROPER SELECTION OF SIZE, IMPROPER POSITIONING OR IMPROPER USE MAY RESULT IN SEPTAL TRAUMA OR NECROSIS. -FREQUENT OBSERVATION OF PRONGS POSITION IN PATIENT'S NARES MAY BE NECESSARY. -DISCONTINUE IMMEDIATELY IF SKIN IRRITATION OCCURS. THIS COMPLAINT WILL BE MONITORED FOR TRENDING PURPOSES AND IS ADDED TO THE RELATED LOGS AND CHARTS.

    Description of Event or Problem · 1

    INJURY TO CARTILAGE OF THE NOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541369 NEOTECH PRODUCTS LLC RAM CANNULA CAT NEOTECH PRODUCTS LLC N4900 2016-0411

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention