BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERO

    MDR report key: 11638946 · Received April 8, 2021

    Report

    Report Number
    3014660737-2021-00001
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 10, 2021
    Report Date
    April 9, 2021
    Manufacturer
    HERO HEALTH, INC
    Product Code
    NXB
    PMA / PMN Number
    NONE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER REPORTED THAT SOMETHING FELL INTO THE MEDICATION CUP DURING AN ATTEMPTED MEDICATION DISPENSE. THE OBJECT WAS REMOVED FROM THE MEDICATION CUP BEFORE ANY MEDICATIONS WERE INGESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529941 HERO SOLID MEDICATION DISPENSER NXB HERO HEALTH, INC H-100

    Patients

    Seq Age Sex Outcome Treatment
    1