BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERO BIOTECH

    MDR report key: 14787217 · Received June 22, 2022

    Report

    Report Number
    MW5110439
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    October 19, 2020
    Report Date
    June 20, 2022
    Manufacturer
    VERO BIOTECH, LLC
    Product Code
    MRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    [VERO BIOTECH] USE FOR COVID-19 UNDER EMERGENCY USE AUTHORIZATION (EUA): WHEN DEMO WAS DONE TO RTS, THE DEVICE SHUT DOWN (MAJOR RISK ON FLIGHT TRANSPORT AND IF ON PATIENT IN HOSPITAL OR HOME) AND THE BACKUP WAS TURNED ON BUT THIS WAS A MAJOR CONCERN. THE PRODUCT ALSO DOES NOT FULLY DEPLETE THE INO FROM THE PERMANGANATE SCRUBBER LEADING TO EXPOSURE OF INO TO THE USER/PATIENT (FALSE ADVERTISEMENT). THE TEAM USED AN APP WHERE THEY COULD COMMUNICATE ABOUT ISSUES INSTEAD OF EMAILS TO HIDE PROBLEMS/CONCERNS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135699 VERO BIOTECH APPARATUS, NITRIC OXIDE DELIVERY MRN VERO BIOTECH, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other