BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO 100

    MDR report key: 18702239 · Received February 14, 2024

    Report

    Report Number
    3014660737-2024-75410
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    February 5, 2024
    Report Date
    February 14, 2024
    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 A FUTURE DOSE, AND THE DEVICE OFFERED THE SAME DOSE 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. THE DEVICE WAS RETURNED PHYSICALLY DAMAGED MOST LIKELY DUE TO IMPROPER PACKAGING FOR TRANSIT. THE HERO ENGINEERS WERE UNABLE TO PREFORM A PROPER DEVICE EVALUATION.

    Additional Manufacturer Narrative · 0

    THE USER PROACTIVELY DISPENSED A FUTURE DOSE, AND THE DEVICE OFFERED THE SAME DOSE 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.

    Description of Event or Problem · 0

    ON (B)(6) 2024 THE USER REPORTED THAT THEY MIGHT HAVE TAKEN AN ADDITIONAL DOSE OF THEIR MORNING MEDICATION AND FELT SLEEPY. ON (B)(6) 2024 THE USER INFORMED US THAT THEY HAD TO VISIT THE HOSPITAL DUE TO TAKING DOUBLE DOSES ON THE PREVIOUS DAY. PER THE AVAILABLE INFORMATION FROM THE CALL, THE USER MENTIONED THAT THEY DID NOT EXPERIENCE ANY SEVERE SYMPTOMS. ON (B)(6) 2024 AFTER TALKING TO HER DAUGHTER WHO IS A LAWYER, THE USER THEN REPORTED THAT THEY ALMOST DIED, AND HAD TO BE IN THE HOSPITAL FOR TWO DAYS. PER THE USER THEY GOT AN IV TO RUN THE MEDICATION OUT OF THEIR SYSTEM. NO ADDITIONAL INFORMATION ON THE USERS CONDITION IS AVAILABLE AT THIS TIME. PER THE DEVICE HISTORY LOGS THE CUSTOMERS CLAIMS WERE CONFIRMED. THE USER PROACTIVELY DISPENSED A FUTURE DOSE, AND THE DEVICE OFFERED THE SAME DOSE TO BE DISPENSED AGAIN. THE USER HAD AN OPTION TO SKIP THE DOSE WHICH WAS OFFERED. THE DEVICE IS NOT A LOCK BOX BY DESIGN.

    Description of Event or Problem · 0

    ON 02/05/2024 THE USER REPORTED THAT THEY MIGHT HAVE TAKEN AN ADDITIONAL DOSE OF THEIR MORNING MEDICATION AND FELT SLEEPY. ON 02/06/2024 THE USER INFORMED US THAT THEY HAD TO VISIT THE HOSPITAL DUE TO TAKING DOUBLE DOSES ON THE PREVIOUS DAY. PER THE AVAILABLE INFORMATION FROM THE CALL, THE USER MENTIONED THAT THEY DID NOT EXPERIENCE ANY SEVERE SYMPTOMS. ON 02/07/2024 AFTER TALKING TO HER DAUGHTER WHO IS A LAWYER, THE USER THEN REPORTED THAT THEY ALMOST DIED, AND HAD TO BE IN THE HOSPITAL FOR TWO DAYS. PER THE USER THEY GOT AN IV TO RUN THE MEDICATION OUT OF THEIR SYSTEM. NO ADDITIONAL INFORMATION ON THE USERS CONDITION IS AVAILABLE AT THIS TIME. PER THE DEVICE HISTORY LOGS THE CUSTOMERS CLAIMS WERE CONFIRMED. THE USER PROACTIVELY DISPENSED A FUTURE DOSE, AND THE DEVICE OFFERED THE SAME DOSE TO BE DISPENSED AGAIN. THE USER HAD AN OPTION TO SKIP THE DOSE WHICH WAS OFFERED. THE DEVICE IS NOT A LOCK BOX BY DESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70301 HERO 100 DISPENSER, SOLID MEDICATION NXB HERO HEALTH, INC. H100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization