BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO

    MDR report key: 10286244 · Received July 16, 2020

    Report

    Report Number
    3014660737-2020-00001
    Event Type
    Injury
    Date Received
    July 16, 2020
    Date of Event
    June 18, 2020
    Report Date
    July 16, 2020
    Manufacturer
    HERO HEALTH, INC.
    Product Code
    NXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEIR MOTHER WAS ADMITTED TO THE HOSPITAL DUE TO THEIR HERO (MODEL NUMBER H-100) FAILING TO DISPENSE THE CORRECT MEDICATION. IN THE COMMUNICATIONS, THE CUSTOMER INDICATED THAT THEIR MOTHER HAD EPILEPSY. FURTHER ATTEMPTS TO REACH OUT FOR ADDITIONAL INFORMATION AND DEVICE RETURN HAVE BEEN UNSUCCESSFUL. PER THE DEVICE INSTRUCTION MANUAL, THE DEVICE IS NOT INTENDED TO REPLACE AN ATTENTIVE CAREGIVER,SHOULD ONE BE REQUIRED BY THE USER. IN ADDITION, THE INSTRUCTION MANUAL AND MEDICAL DEVICE LABELING INSTRUCTS THE USER TO "BE SURE TO VERIFY THAT THE TYPES OF PILLS AND NUMBER OF PILLS DISPENSED MATCH THE PRESCRIBED DOSAGE. IN CASES WHERE THE END USER IS INCAPABLE OF VERIFYING ACCURACY, AS STATED ABOVE, PLEASE ENSURE THAT PILL DISPENSE ACCURACY IS BEING VERIFIED BY PERSON(S) TRUSTED BY THE END USER, I.E. A CAREGIVER, A HEALTHCARE AIDE, AND/OR A HEALTHCARE PROFESSIONAL." THE LABELING ALSO INDICATES THAT HERO CANNOT GUARANTEE ACCURACY OF MEDICATION DISPENSES DUE TO POTENTIAL HUMAN ERROR AND/OR MECHANICAL AND SOFTWARE DISCREPANCIES. NO ADDITIONAL INFORMATION ABOUT THE STATUS OF THE USER, DEVICE, OR DEFINITIVE ROOT CAUSE IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR MOTHER WAS ADMITTED TO THE HOSPITAL BECAUSE THEIR HERO (MODEL NUMBER H-100) PILL DISPENSER DID NOT DISPENSE THE CORRECT AMOUNT OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746838 HERO HERO NXB HERO HEALTH, INC. H-100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization