BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK READ RECTAL THERMOMETER

    MDR report key: 18781801 · Received February 23, 2024

    Report

    Report Number
    MW5151967
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    February 12, 2024
    Report Date
    February 12, 2024
    Manufacturer
    FRIDABABY LLC
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FRIDA QUICK TEMP THERMOMETER MODEL 61-088: USED ON TWO WEEK OLD PREMATURE NEWBORN AS SHE HAD NASAL CONGESTION AT HOME AND IT CONSISTENTLY RESULTED IN LOWER THAN NORMAL RANGE TEMPS. WAS ADVISED BY NURSE LINE OF BABY'S PEDIATRICIAN TO GO TO PEDS URGENT CARE. THERE THE BABY HAD A NORMAL TEMPERATURE WITH THEIR THERMOMETER AND I IMMEDIATELY CHECKED WITH THE FRIDA DEVICE I BROUGHT WITH ME AFTER (AS IN RIGHT AFTER THE DOCTOR PULLED OUT THEIR RECTAL THERMOMETER I PUT IT IN) AND THE FRIDA DEVICE SHOWED OVER ONE DEGREE LOWER THAN THE OFFICE DEVICE, AGAIN PUTTING THE BABY'S TEMPERATURE OUT OF RANGE (LOWER), LIKELY FALSELY. I SEARCHED FOR ANY CONCERNS OF INACCURATE READINGS FROM FRIDA DEVICES AND SAW A COMPLAINT MADE FROM A 2021 BOUGHT DEVICE ON HERE; I'M WORRIED THE INACCURACIES ARE REAL AND THERE LIES FURTHER RISKS TO NEW PARENTS OF UNDUE ANXIETY AND MONEY/TIME LOSS FROM POTENTIAL TOTALLY UNNECESSARY CARE VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103524 QUICK READ RECTAL THERMOMETER THERMOMETER, ELECTRONIC, CLINICAL FLL FRIDABABY LLC 61-088 51002805216294

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DA Female