BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO 100

    MDR report key: 17001580 · Received May 25, 2023

    Report

    Report Number
    3014660737-2023-56895
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    May 10, 2023
    Report Date
    May 25, 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

    AFTER CLOG ISSUE WAS DISCOVERED UPON INVESTIGATING WHICH RESULTED IN A FALSE POSITIVE PILL DISPENSE EVENT. THE DEVICE ALWAYS ASKS THE USER TO VERIFY THE NUMBER OF PILS BEFORE CONSUMPTION. MANUAL DISPENSING OF MEDICATION IS AVAILABLE WHEN AUTOMATIC FAILURES OCCUR. 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 05/10/2024 THE CAREGIVER REPORTED ONGOING AUTOMATIC DISPENSING ISSUES WITH THEIR DEVICE, WHICH MAY HAVE LED TO THE END USER GOING TO THE EMERGENCY ROOM. THE CAREGIVER WAS ASKED TO CONFIRM IF AN ADVERSE EVENT HAD OCCURRED AND DID NOT PROVIDE ADDITIONAL INFORMATION IN REGARDS TO THE IMPACT OF THIS EVENT ON THE USER'S HEALTH. THE CAREGIVER WAS NOT COMFORTABLE SHARING ANY ADDITIONAL INFORMATION ON THE END USER'S BEHALF. AFTER THE INVESTIGATION THE ROOT CAUSE OF THE REPORTED EVENT IS A FILTER CLOG CAUSING THE POTENTIAL FOR A FALSE POSITIVE PILL DISPENSE EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2023 THE CAREGIVER REPORTED ONGOING AUTOMATIC DISPENSING ISSUES WITH THEIR DEVICE, WHICH MAY HAVE LED TO THE END USER GOING TO THE EMERGENCY ROOM. THE CAREGIVER WAS ASKED TO CONFIRM IF AN ADVERSE EVENT HAD OCCURRED AND DID NOT PROVIDE ADDITIONAL INFORMATION IN REGARDS TO THE IMPACT OF THIS EVENT ON THE USER'S HEALTH. THE CAREGIVER WAS NOT COMFORTABLE SHARING ANY ADDITIONAL INFORMATION ON THE END USER'S BEHALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516169 HERO 100 DISPENSER, SOLID MEDICATION NXB HERO HEALTH, INC. H100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization