BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRIDABABY 3-IN-1TRUE TEMPERATURE DIGITAL THERMOMETER

    MDR report key: 15632291 · Received October 18, 2022

    Report

    Report Number
    MW5112710
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    October 12, 2022
    Report Date
    October 14, 2022
    Manufacturer
    FRIDABABY LLC.
    Product Code
    FLL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE CHECKED OUR NEWBORNS TEMPERATURE USING THE FRIDABABY 3 IN 1 THERMOMETER RECEIVING A READING OF 100.5F ON A RECTAL TEMPERATURE. WE WERE ADVISED TO GO THE EMERGENCY DEPARTMENT AND OUR NEWBORN WAS HOSPITALIZED AND UNDERWENT INVASIVE PROCEDURES (LUMBAR PUNCTURE) BASED ON THIS TEMPERATURE READING. SHE NEVER REGISTERED A FEVER IN THE HOSPITAL. I WENT HOME AND RETRIEVED THE FRIDABABY THERMOMETER AND TOOK SEVERAL RECTAL TEMPERATURES IN ORDER TO CORRELATE THE THERMOMETER WITH HOSPITAL THERMOMETER READINGS. THE FRIDABABY THERMOMETER CONTINUED TO RESULT A RECTAL TEMPERATURE OF 100.5 F THROUGHOUT THE ADMISSION DESPITE OUR NEWBORN NEVER REGISTERING A TEMPERATURE ON ANY OTHER THERMOMETER USED THROUGHOUT THE HOSPITALIZATION. ALL OF HER CULTURES AND LAB WORK WERE COMPLETELY NORMAL. IT APPEARS THE FRIDABABY THERMOMETER IS GIVING AN INACCURATE AND FALSELY HIGH READING WHICH LEAD TO AN UNNECESSARY HOSPITALIZATION IN OUR CASE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495547 FRIDABABY 3-IN-1TRUE TEMPERATURE DIGITAL THERMOMETER THERMOMETER, ELECTRONIC, CLINICAL FLL FRIDABABY LLC. 61-067 51002804216292

    Patients

    Seq Age Sex Outcome Treatment
    1 17 DA Female Hospitalization