BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOPCO

    MDR report key: 9734840 · Received February 20, 2020

    Report

    Report Number
    1422443-2020-00002
    Event Type
    Injury
    Date Received
    February 20, 2020
    Date of Event
    January 18, 2020
    Report Date
    February 20, 2020
    Manufacturer
    SEJOY ELECTRONICS & INSTRUMENTS CO, LTD
    Product Code
    FLL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT REGISTERED A TODDLER'S TEMPERATURE AT 100.5F ORALLY. THE CHILD HAD A SEIZURE, AN AMBULANCE WAS CALLED, AND THE CHILD WAS TAKEN TO THE HOSPITAL, WHERE HIS TEMPERATURE WAS MEASURED AT 104F. THIS WAS THE FIRST USE OF THE DEVICE. THE REPORTER (THE TODDLER'S FATHER) TRIED THE UNIT ON HIMSELF AND GOT READINGS BETWEEN 95.8-96F. AS OF (B)(6) 2020 CONVERSATION WITH REPORTER, THE CHILD IS DOING BETTER. ALTHOUGH IT WAS INDICATED THAT THE SAMPLE WAS AVAILABLE FOR EVALUATION, IT HAS NOT BEEN RECEIVED AS OF THIS WRITING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194783 TOPCO 10-SECOND FLEXIBLE TIP THERMOMETER FLL SEJOY ELECTRONICS & INSTRUMENTS CO, LTD 87-736-001 5977600119627

    Patients

    Seq Age Sex Outcome Treatment
    1 19 MO Hospitalization