BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO100

    MDR report key: 16495117 · Received March 7, 2023

    Report

    Report Number
    3014660737-2023-48710
    Event Type
    Injury
    Date Received
    March 7, 2023
    Date of Event
    February 13, 2023
    Report Date
    March 3, 2023
    Manufacturer
    HERO HEALTH, INC
    Product Code
    NXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER REPORTED BEING ALL GOOD. NO FURTHER EVENTS ARE REPORTED. 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.

    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 2/2013 THE CAREGIVER REACHED OUT AND REPORTED THAT THEY RECEIVED A PUSH NOTIFICATIONS IN THE HERO MOBILE APP THAT THE CARTRIDGE 7 WAS RUNNING LOW WHICH THEY IGNORED. UPON FURTHER INVESTIGATION IT WAS REPORTED THAT THE USER WAS GOING THROUGH A MEDICATION INDUCED CRISIS AND AN AMBULANCE WAS CALLED ON (B)(6) 2012. THEY SWITCHED TO PILL CASES. ON (B)(6) 2015 AND (B)(6) 2023 FOLLOW UPS THE CUSTOMER REPORTED EVERYTHING WAS FINE.

    Description of Event or Problem · 0

    ON (B)(6) THE CAREGIVER REACHED OUT AND REPORTED THAT THEY RECEIVED A PUSH NOTIFICATIONS IN THE HERO MOBILE APP THAT THE CARTRIDGE 7 WAS RUNNING LOW WHICH THEY IGNORED. UPON FURTHER INVESTIGATION IT WAS REPORTED THAT THE USER WAS GOING THROUGH A MEDICATION INDUCED CRISIS AND AN AMBULANCE WAS CALLED ON (B)(6). THEY SWITCHED TO PILL CASES. ON (B)(6) AND (B)(6) FOLLOW UP THE CUSTOMER REPORTED EVERYTHING WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659771 HERO100 DISPENSER, SOLID MEDICATION NXB HERO HEALTH, INC H100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization ABILIFY 10 MG| ABILIFY 10 MG