BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7-DAY MEDIPLANNER

    MDR report key: 5831284 · Received July 28, 2016

    Report

    Report Number
    2182780-2016-00009
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Date of Event
    July 8, 2016
    Report Date
    July 28, 2016
    Manufacturer
    COMPASS HEALTH BRANDS
    Product Code
    NXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT HE WAS DUMPING HIS PILLS OUT OF HIS CONTAINER, AND A PLASTIC PIECE CAME OUT OF THE MEDICINE PLANNER, IN WHICH HE ALMOST TOOK WITH HIS OTHER PILLS. WHEN YOU OPEN THE PURPLE ROW (OF THE REPORTED DEFECTIVE PLANNER), IT LOOKS LIKE THE PLASTIC CUTTING PRESS USED DURING MANUFACTURING OF THE DEVICE MAY NEED TO BE SHARPENED DUE TO THE EXCESS PLASTIC PIECE LEFTOVER (IN WHICH CUSTOMER IS REPORTING ON). THE CUSTOMER ALSO SUGGESTED THAT THE AIR PRESSURE THAT WOULD BLOW EXCESS PLASTIC PIECES WAY MAY NEED TO BE ADJUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483937 7-DAY MEDIPLANNER MEDICINE PLANNER NXQ COMPASS HEALTH BRANDS 70069B

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other