BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPASS HEALTH BRANDS

    MDR report key: 9362495 · Received November 22, 2019

    Report

    Report Number
    3012316249-2019-00039
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Report Date
    November 22, 2019
    Manufacturer
    COMPASS HEALTH BRANDS
    Product Code
    KYW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CALIBRATIONS ON THE MEDICINE SPOONS ARE NOT PLACED ON THE SPOON CORRECTLY. THE DOSAGE OF MEDICINE WILL BE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161155 COMPASS HEALTH BRANDS MED. SPOON CLEAR HOT STAMPED CELLO WRAPPED KYW COMPASS HEALTH BRANDS 88881PL-MEI

    Patients

    Seq Age Sex Outcome Treatment
    1