BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOPCO

    MDR report key: 9506946 · Received December 20, 2019

    Report

    Report Number
    1422443-2019-00007
    Event Type
    Injury
    Date Received
    December 20, 2019
    Report Date
    December 20, 2019
    Manufacturer
    HANGZHOU SEJOY ELECTRONICS & INSTRUMENTS CO, LTD
    Product Code
    FLL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DIGITAL THERMOMETER WAS READING LOW. THE THERMOMETER WAS USED ON THE REPORTER'S (B)(6)-YEAR-OLD SON AND DISPLAYED A READING OF 94.7 REPEATEDLY.. THE MOTHER WAS CONCERNED AND EXPRESSED THE CHILD HAD SYMPTOMS, SUCH AS BEING SWEATY, AND THE CHILD WAS TAKEN TO THE ER. THE ER MEASURED THE CHILD'S TEMPERATURE TO BE 104 F RECTALLY. THE REPORTER TRIED THE UNIT IN HER ARMPIT, AND GOT A READING OF 96.8 REPEATEDLY. THE UNIT WAS IN SERVICE FOR LESS THAN A YEAR. THE DEVICE WAS RETURNED AND EVALUATED AND WAS FOUND TO BE FUNCTIONING PROPERLY AND APPEARED TO BE GIVING ACCURATE TEMPERATURE READINGS. THE DEVICE WILL BE SENT BACK TO THE MANUFACTURER FOR THEIR VERIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295167 TOPCO 10 SECOND FLEXIBLE TIP DIGITAL THERMOMETER FLL HANGZHOU SEJOY ELECTRONICS & INSTRUMENTS CO, LTD 87-736-001 59776010186163

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization