BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERO HEALTH PILL DISPENSER

    MDR report key: 11019231 · Received December 15, 2020

    Report

    Report Number
    MW5098401
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    December 13, 2020
    Report Date
    December 13, 2020
    Manufacturer
    HERO HEALTH INC.
    Product Code
    NXB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS IS IN RESPONSE TO THE HERO HEALTH PILL DISPENSER. IT HAS A FEATURE WHERE THE CAREGIVER CAN LIMIT THE AMOUNT OF MEDICATION A PATIENT CAN HAVE ACCESS TO. TURNS OUT ALL ANYONE HAS TO DO IS PRESS "MEDICATION", "REFILL" THEN THE MEDICATION NAME AND THE DOOR POPS OPEN AND ANYONE, PATIENT OR ANYONE ELSE, CAN HAVE ACCESS TO ALL THE PATIENT'S MEDICATIONS. YOU CAN PUT A PASSCODE INTO THE SYSTEM, BUT IT WILL NOT EVEN DISPENSE A SCHEDULED DOSE WITHOUT YOU ENTERING THE PASSCODE SO IF YOU DO SET A PASSCODE THE CAREGIVER WILL HAVE TO BE THERE TO ENTER IT WHICH DEFEATS THE PURPOSE OF HAVING IT. I CONTACTED HERO ABOUT THIS PROBLEM, AND THEY STATED IT IS NOT MEANT TO BE A SECURE DEVICE. I DID NOT WANT A SAFE. I SIMPLY WANTED A PATIENT TO NOT ACCESS MEDS ON AN AS WANTED BASIS. SELF-MEDICATION AND MEDICATION THEFT ARE WIDE OPEN ON THIS SYSTEM. THERE IS A SIMPLE FIX. ADD A BUTTON ON THE PHONE APP THAT STATES "LOCK DOOR". IT'S REALLY THAT SIMPLE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474938 HERO HEALTH PILL DISPENSER DISPENSER, SOLID MEDICATION NXB HERO HEALTH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR