BEUDAMED
    FDA Adverse Event Death Summary report: N

    HERO 100

    MDR report key: 16501802 · Received March 8, 2023

    Report

    Report Number
    3014660737-2023-48792
    Event Type
    Death
    Date Received
    March 8, 2023
    Date of Event
    December 11, 2022
    Report Date
    March 7, 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

    NO ISSUE WAS FOUND IN THE RETURNED DEVICE. THE DEVICE PASSED ALL FUNCTIONAL TESTS. THE ROOT CAUSE OF THE REPORTED INCIDENT CANNOT BE CONFIRMED CONCLUSIVELY, AS THE ISSUE COULD NOT BE REPRODUCED IN THE RETURNED DEVICE. 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

    THE CAREGIVER CALLED ON (B)(6) 2023 TO REPORT THAT THEY RECEIVED NOTIFICATIONS THROUGH THE HERO MOBILE APP THAT THE USER WAS MISSING SCHEDULED MEDICATIONS SINCE (B)(6) 2022 AND WAS DISPENSING ON-DEMAND DOSES OVER THE PAST THREE DAYS, AS THE DEVICE WAS INTENDED TO BE USED. PRIOR TO THIS THE USER WENT TO THE HOSPITAL ON (B)(6) 2022 AFTER FALLING AND HITTING HER HEAD AND WAS RELEASED ON THE SAME DAY. THE CAREGIVER REPORTED THE USER HAD CHRONIC ILLNESSES AND THEY PASSED AWAY OF NATURAL CAUSES ON (B)(6) 2022.

    Description of Event or Problem · 0

    THE CAREGIVER CALLED ON 2/11/2023 TO REPORT THAT THEY RECEIVED NOTIFICATIONS THROUGH THE HERO MOBILE APP THAT THE USER WAS MISSING SCHEDULED MEDICATIONS SINCE (B)(6) 2022 AND WAS DISPENSING ON-DEMAND DOSES OVER THE PAST THREE DAYS, AS THE DEVICE WAS INTENDED TO BE USED. PRIOR TO THIS THE USER WENT TO THE HOSPITAL ON (B)(6) 2022 AFTER FALLING AND HITTING HER HEAD AND WAS RELEASED ON THE SAME DAY. THE CAREGIVER REPORTED THE USER HAD CHRONIC ILLNESSES AND THEY PASSED AWAY OF NATURAL CAUSES ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136221 HERO 100 DISPENSER, SOLID MEDICATION NXB HERO HEALTH, INC H100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death PROMETHAZINE HCI 25MG| PROMETHAZINE HCI 25MG