BRAUN
Received Nov 5, 2025 · Event occurred Sep 27, 2025
Report 1314800-2025-00029 · MDR key 23479393
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT3030WELot number
13623FAM
Product problems
- False Negative Result
- False Negative Result
Patient
NA · Unknown
- Fever
- Fever
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 ALLEGEDLY PROVIDED FALSE NEGATIVE READINGS ON THEIR CHILD (AGE NOT SPECIFIED). THE DEVICE ALLEGEDLY DISPLAYED 36-37°C, WHILE A SUBSEQUENT RECTAL MEASUREMENT AND AN ALTERNATE DIGITAL EAR THERMOMETER (BRAND UNSPECIFIED) INDICATED A FEVER OF 39°C. IT IS UNCLEAR WHETHER THE 39°C READING WAS CONFIRMED BY A PHYSICIAN'S THERMOMETER. THE CONSUMER STATED THAT TREATMENT WAS DELAYED AND THAT THEY CONSULTED A PEDIATRICIAN. NO COMPLICATIONS WERE REPORTED, AND THE CHILD'S OUTCOME IS UNKNOWN. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.