BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOTECH

    MDR report key: 17390900 · Received July 24, 2023

    Report

    Report Number
    MW5120017
    Event Type
    Other
    Date Received
    July 24, 2023
    Date of Event
    July 12, 2023
    Report Date
    July 21, 2023
    Manufacturer
    NEOTECH PRODUCTS, LLC.
    Product Code
    BXJ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 42 WEEK INFANT WHO WAS ADMITTED TO NICU FOLLOWING BIRTH NEEDING RESPIRATORY SUPPORT VIA NASAL CANNULA. NEOTECH FOAM BARRIER IN PLACE. INFANT FOUND TO BE DESATURATING AND CHOKING ON FOAM BARRIER. ONCE RN REMOVED FOAM BARRIER INFANT RECOVERED IMMEDIATELY. FOAM BARRIERS REMOVED FROM UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635040 NEOTECH CLIP, NOSE BXJ NEOTECH PRODUCTS, LLC. N420 2022-0101

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Female