BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO

    MDR report key: 8729509 · Received June 24, 2019

    Report

    Report Number
    3014660737-2019-90001
    Event Type
    Injury
    Date Received
    June 24, 2019
    Date of Event
    May 26, 2019
    Report Date
    June 24, 2019
    Manufacturer
    HERO HEALTH, INC.
    Product Code
    NXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    USER DISPENSED OVER 12 UNSCHEDULED PILLS BY PRESSING THE DISPENSE BUTTON REPEATEDLY. THE FOLLOWING DAY, A CAREGIVER TOOK THE USER TO THE ER. PER USER'S CAREGIVER, USER IS EXPECTED TO MAKE A FULL RECOVERY. PER THE DEVICE INSTRUCTION MANUAL, THE DEVICE IS NOT INTENDED TO REPLACE AN ATTENTIVE CAREGIVER, SHOULD ONE BE REQUIRED BY THE USER. THE USER'S CAREGIVER DID NOT SET UP A CAREGIVER ACCOUNT, WHICH WOULD HAVE ALERTED THE CAREGIVER WITH AN APP NOTIFICATION WHEN THE FIRST UNSCHEDULED PILL WAS DISPENSED BY THE END USER. THE EVENT WAS CAUSED BY USER ERROR, IN THAT THE REDUNDANT MEANS TO PREVENT OR MITIGATE THIS TYPE OF EVENT - DISPENSING MULTIPLE UNSCHEDULED MEDICATIONS - WERE PURPOSELY NOT UTILIZED BY THE PATIENT'S CAREGIVER WHO SET UP THE DEVICE.

    Description of Event or Problem · 1

    USER DISPENSED OVER 12 UNSCHEDULED PILLS BY PRESSING THE DISPENSE BUTTON REPEATEDLY. THE FOLLOWING DAY, A CAREGIVER TOOK THE USER TO THE ER. PER USER'S CAREGIVER, USER IS EXPECTED TO MAKE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522316 HERO HERO DISPENSER - SOLID MEDICATION NXB HERO HEALTH, INC. H-100

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization