BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AICURE AIBREATHE

    MDR report key: 8591404 · Received May 7, 2019

    Report

    Report Number
    MW5086461
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    April 10, 2019
    Report Date
    April 29, 2019
    Manufacturer
    AI CURE LLC
    Product Code
    NXQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HELLO, I AM ON A CLINICAL TRIAL FOR MY SICKNESS AND THEY TOLD ME TO USE AN APP ON MY PHONE TO TELL ME WHAT PILLS TO TAKE AND WHEN. NOW IT'S BEEN MONTHS ON THIS MEDICINE AND THEY TOLD ME THAT THE APP IS TELLING ME TO TAKE THE WRONG MEDICATIONS AND I'M STILL FEELING PROBLEMS. THE APP IS FROM AICURE AND IT IS TELLING ME THE WRONG THING. WWW.AICURE.COM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382725 AICURE AIBREATHE REMINDER, MEDICATION NXQ AI CURE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention