BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO 100

    MDR report key: 18100073 · Received November 9, 2023

    Report

    Report Number
    3014660737-2023-69235
    Event Type
    Injury
    Date Received
    November 9, 2023
    Date of Event
    October 6, 2023
    Report Date
    November 9, 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 USER REPORTED SUBSTANCE ABUSE ISSUES AND WAS TAKING CONTROLLED PAIN MEDICATIONS. THE ROOT CAUSE OF THE REPORTED INCIDENT CANNOT BE CONFIRMED CONCLUSIVELY, AS THE DEVICE WAS RETURNED PHYSICALLY DAMAGED, SUCH THAT IT COULD NOT BE FUNCTIONALLY TESTED. 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 USER REPORTED SUBSTANCE ABUSE ISSUES AND WAS TAKING CONTROLLED PAIN MEDICATIONS. 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 10/23/2023, THE USER REPORTED AN ACCIDENTAL OVERDOSE BY OPENING THE HERO SMART DISPENSER DOOR WITH A PILL ACCESS KEY AND TAKING THE MEDICATIONS MANUALLY. PER USER THEY OVERDOSED ON PAIN MANAGEMENT PILLS AND CONTROLLED SUBSTANCES. BASED ON THE DEVICE LOGS INVESTIGATION THERE WAS NO MALFUNCTION IDENTIFIED. THE DEVICE WAS RETURNED AND EXAMINATION WAS DONE, HOWEVER THE ROOT CAUSE OF THE REPORTED INCIDENT CANNOT BE CONFIRMED CONCLUSIVELY, AS THE DEVICE WAS RETURNED PHYSICALLY DAMAGED, SUCH THAT IT COULD NOT BE FUNCTIONALLY TESTED.

    Description of Event or Problem · 0

    ON (B)(6) 2023 THE USER REPORTED AN ACCIDENTAL OVERDOSE BY OPENING THE HERO SMART DISPENSER DOOR WITH A PILL ACCESS KEY AND TAKING THE MEDICATIONS MANUALLY. PER USER THEY OVERDOSED ON PAIN MANAGEMENT PILLS AND CONTROLLED SUBSTANCES. BASED ON THE DEVICE LOGS INVESTIGATION THERE WAS NO MALFUNCTION IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805526 HERO 100 DISPENSER, SOLID MEDICATION NXB HERO HEALTH, INC H100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization CONTROLLED MEDICATION| CONTROLLED MEDICATION