BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPENSER, SOLID MEDICATION

    MDR report key: 15667978 · Received October 24, 2022

    Report

    Report Number
    MW5112829
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    October 20, 2022
    Report Date
    October 20, 2022
    Manufacturer
    HERO HEALTH, INC.
    Product Code
    NXB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE A MEDICATION DISPENSER THAT HAS BEEN FAULTY. THIS IS THE 3RD UNIT I WAS GIVEN. AT TIMES, IT WILL DISPENSE A MEDICATION TWICE AT THE SAME TIME WHEN I ONLY NEEDED ONE PILL. SOMETIMES, IT WONT EVEN DISPENSE A PILL WHEN I NEED IT. THE COMPANY OFFERED TO REPLACE THE UNIT BUT EVERY UNIT I USE IT SEEMS TO BE FAULTY. MAYBE THEIR PRODUCT SHOULD BE REMOVED FROM THE MARKET UNTIL IT WORKS PROPERLY. IT CAN SEND SOMEONE TO THE HOSPITAL IF THE PERSON CAN NOT SEE THE PILLS CORRECTLY OR TAKES TOO MUCH WHEN THE MACHINE GIVES THE WRONG AMOUNT. IT ONCE DISPENSED 2 BLOOD PRESSURE PILLS INSTEAD OF ONE AND L CAUGHT IT IN TIME. THIS NEEDS TO BE LOOKED INTO. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2721025 DISPENSER, SOLID MEDICATION DISPENSER, SOLID MEDICATION NXB HERO HEALTH, INC.
    2721026 DISPENSER, SOLID MEDICATION DISPENSER, SOLID MEDICATION NXB HERO HEALTH, INC.
    2721027 DISPENSER, SOLID MEDICATION DISPENSER, SOLID MEDICATION NXB HERO HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male