BRAUN
Received Jan 2, 2025 · Event occurred Nov 28, 2024
Report 1314800-2024-00026 · MDR key 21056772
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT3030WELot number
UNKNOWN
Product problems
- False Negative Result
- False Negative Result
Patient
12 MO · Unknown
- Fever
- Viral Infection
- Fever
- Viral Infection
Narrative
Additional Manufacturer Narrative
KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.
Description of Event or Problem
A CONSUMER REPORTED THAT THEIR THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON THEIR ONE-YEAR-OLD INFANT. THE DEVICE ALLEGEDLY GAVE READINGS OF 36°C FOR TWO DAYS, AND A FEVER OF 40°C WAS LATER MEASURED BY A DOCTOR. IT IS UNKNOWN WHETHER THE CONSUMER TOOK A MEASUREMENT ON THE SAME DAY THEY BROUGHT THE CHILD TO A HOSPITAL, WHERE A FEVER WAS CONFIRMED. THE CHILD HAS BEEN HOSPITALIZED WITH A VIRAL INFECTION FOR FOUR DAYS AND THEIR CURRENT HEALTH STATUS IS UNKNOWN. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.