BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO 100

    MDR report key: 18236611 · Received November 30, 2023

    Report

    Report Number
    3014660737-2023-70833
    Event Type
    Injury
    Date Received
    November 30, 2023
    Date of Event
    November 14, 2023
    Report Date
    November 30, 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 PROACTIVELY DISPENSED FUTURE DOSES, AND THE DEVICE OFFERED THE SAME DOSES TO BE DISPENSED AGAIN. THE DEVICE IS NOT A LOCK BOX BY DESIGN. 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 PROACTIVELY DISPENSED FUTURE DOSES, AND THE DEVICE OFFERED THE SAME DOSES TO BE DISPENSED AGAIN. THE DEVICE IS NOT A LOCK BOX BY DESIGN. 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. RETURN OF THE DEVICE WAS REQUESTED HOWEVER THE CUSTOMER DECLINED TO RETURN THE DEVICE AFTER MULTIPLE REQUESTS. AS A RESULT, NO PHYSICAL EVALUATION WILL BE COMPLETED.

    Description of Event or Problem · 0

    ON 11/15/2023 THE USER REPORTED THEY HAVE OVERDOSED ON NARCOTICS (PAIN MEDICATIONS) AND METFORMIN, WHICH CAUSED AN EXTREME STOMACH UPSET, AND THEY HAVE TALKED TO A DOCTOR. ON (B)(6) 2023 THE USER CONFIRMED THEY HAVE OVERDOSED ON NARCOTICS AND THAT THE ISSUE HAPPENED THREE DAYS AGO. MOREOVER THEY REPORTED USING NARCAN, BECAUSE THEY HAD A RESPIRATORY FAILURE AND HIT THE FLOOR. ON THE SAME CALL, THE USER CONFIRMED FEELING FINE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THE USER REPORTED THEY HAVE OVERDOSED ON NARCOTICS (PAIN MEDICATIONS) AND METFORMIN, WHICH CAUSED AN EXTREME STOMACH UPSET, AND THEY HAVE TALKED TO A DOCTOR. ON (B)(6) 2023, THE USER CONFIRMED THEY HAVE OVERDOSED ON NARCOTICS AND THAT THE ISSUE HAPPENED THREE DAYS AGO. MOREOVER THEY REPORTED USING NARCAN, BECAUSE THEY HAD A RESPIRATORY FAILURE AND HIT THE FLOOR. ON THE SAME CALL, THE USER CONFIRMED FEELING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770989 HERO 100 DISPENSER, SOLID MEDICATION NXB HERO HEALTH, INC H100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other NARCOTICS.| NARCOTICS.