BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO100

    MDR report key: 17948848 · Received October 17, 2023

    Report

    Report Number
    3014660737-2023-66676
    Event Type
    Injury
    Date Received
    October 17, 2023
    Date of Event
    September 19, 2023
    Report Date
    October 17, 2023
    Manufacturer
    HERO HEALTH, INC
    Product Code
    NXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE HERO DEVICE SHOULD NOT BE USED BY A RECIPIENT OF MEDICATION WHO IS INCAPABLE OF VERIFYING THE ACCURACY OF EACH DISPENSED DOSE (SUCH AS THOSE SUFFERING FROM DEMENTIA OR OTHER COGNITIVE OR PHYSICAL IMPAIRMENTS) UNLESS PILL DISPENSE ACCURACY IS BEING VERIFIED, IN EACH INSTANCE, BY QUALIFIED PERSON(S) TRUSTED BY THE MEDICATION RECIPIENT, I.E. A CAREGIVER, A HEALTHCARE AIDE, AND/OR A HEALTHCARE PROFESSIONAL. THE MEDICATION RECIPIENT (OR A TRUSTED QUALIFIED PERSON) MUST ALWAYS VERIFY THAT THE TYPES OF PILLS AND NUMBER OF PILLS DISPENSED BY THE HERO DEVICE MATCH THE PRESCRIBED OR DESIRED DOSAGE BEFORE INGESTING THE CONTENTS OF THE PILL CUP. THE HERO DEVICE SHOULD NOT BE USED TO DISPENSE MEDICINES THAT HAVE HIGH DOSAGE SENSITIVITY, THAT HAVE A NARROW THERAPEUTIC WINDOW, THAT ARE USED TO TREAT ACUTE CONDITIONS OR THAT ARE USED TO TREAT LIFE-THREATENING EVENTS. EVEN THOUGH THE HERO DEVICE IS CAPABLE OF SUCCESSFULLY AND ACCURATELY DISPENSING MOST WHOLE PILLS LOADED INTO THE DEVICE ON MOST OCCASIONS, HERO CANNOT GUARANTEE THE ACCURACY OF MEDICATION DISPENSED DURING EVERY DISPENSE CYCLE DUE TO THE POTENTIAL FOR HUMAN ERROR AND/OR MECHANICAL AND SOFTWARE LIMITATIONS OR FAILURES.

    Description of Event or Problem · 0

    ON (B)(6) 2023 THE CAREGIVER REPORTED AN ERROR MESSAGE DUE TO A MIS-INSTALLED CARTRIDGE WHICH HOLDS ONE OF THEIR MEDICATIONS AND THE USER NOT TAKING THEIR MEDICATIONS. THE CAREGIVER REPORTED THAT THE ISSUE REMAINED FOR AT LEAST FIVE DAYS, THE USER HAS DEMENTIA AND WAS BEING TAKEN TO THE EMERGENCY ROOM. THE CAREGIVER REACHED OUT AGAIN AND WAS PROVIDED WITH THE RESOLUTION OF THE ISSUE. THEY CONFIRMED NOT HAVING ANY ADDITIONAL ISSUES WITH THE HERO SMART DISPENSER. BASED ON DEVICE LOGS THE USER CONTINUED USING THE HERO SMART DISPENSER ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078381 HERO100 DISPENSER, SOLID MEDICATION NXB HERO HEALTH, INC H100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization