BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO 100

    MDR report key: 16521414 · Received March 10, 2023

    Report

    Report Number
    3014660737-2023-49231
    Event Type
    Injury
    Date Received
    March 10, 2023
    Date of Event
    February 15, 2023
    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

    INSPECTION CONFIRMED NO DEVICE PROBLEMS FOUND. 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 (B)(6) 2023 THE CUSTOMER REPORTED THAT THE HERO SMART UNIT DISPENSED 2 EXTRA BUSPAR MEDICATIONS AND 1 EXTRA CYMBALTA PILL. IT WAS REPORTED THAT THEY WERE HOSPITALIZED DUE TO THE ISSUE. ON (B)(6) 2023 THE CAREGIVER REACHED OUT AND REPORTED THAT THE USER DEVELOPED ARM TREMORS AND THEIR PHYSICIAN WAS CONCERNED WITH THE MEDICATIONS' INTERACTION WITH EACH OTHER (SEROTONIN SYNDROME). IT WAS ALSO REPORTED THAT ON (B)(6) 2023 AROUND NOON THE USER BECAME DISORIENTED WITH AN ALTERED MENTAL STATUS AND WAS TRANSPORTED TO THE EMERGENCY ROOM. AS PER THE CAREGIVER: "WITH OTHER TESTS NORMAL, THE WORKING THEORY WAS SEROTONIN SYNDROME AND THEY BEGAN TO REDUCE HER MEDICATION AMOUNTS. THEY RECOMMENDED CHECK IN TO THE HOSPITAL". UPON FURTHER FOLLOW UP THE USER WAS RELEASED AND IS DOING FINE.

    Description of Event or Problem · 0

    ON 2/15 THE CUSTOMER REPORTED THAT THE HERO SMART UNIT DISPENSED 2 EXTRA BUSPAR MEDICATIONS AND 1 EXTRA CYMBALTA PILL. IT WAS REPORTED THAT THEY WERE HOSPITALIZED DUE TO THE ISSUE. ON 2/17 THE CAREGIVER REACHED OUT AND REPORTED THAT THE USER DEVELOPED ARM TREMORS AND THEIR PHYSICIAN WAS CONCERNED WITH THE MEDICATIONS' INTERACTION WITH EACH OTHER (SEROTONIN SYNDROME). IT WAS ALSO REPORTED THAT ON 2/14 AROUND NOON THE USER BECAME DISORIENTED WITH AN ALTERED MENTAL STATUS AND WAS TRANSPORTED TO THE EMERGENCY ROOM. AS PER THE CAREGIVER: "WITH OTHER TESTS NORMAL, THE WORKING THEORY WAS SEROTONIN SYNDROME AND THEY BEGAN TO REDUCE HER MEDICATION AMOUNTS. THEY RECOMMENDED CHECK IN TO THE HOSPITAL". UPON FURTHER FOLLOW UP THE USER WAS RELEASED AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104329 HERO 100 DISPENSER, SOLID MEDICATION NXB HERO HEALTH, INC H100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization BUSPIRONE HCL 15 MGCYMBALTA 60 MGCYMBALTA 30 MG| BUSPIRONE HCL 15 MGCYMBALTA 60 MGCYMBALTA 30 MG