BRAUN
Received Dec 31, 2025 · Event occurred Nov 20, 2025
Report 1314800-2025-00032 · MDR key 23938613
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT6520BUSLot number
17620K00114
Product problems
- False Negative Result
- False Negative Result
Patient
7 YR · Female
- 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 THE THERMOMETER ALLEGEDLY PROVIDED FALSE NEGATIVE READINGS ON THEIR 7 YEAR OLD DAUGHTER. THE DEVICE ALLEGEDLY DISPLAYED A MEASUREMENT OF 37°C, WHILE A FEVER OF 40°C WAS LATER CONFIRMED BY A DOCTOR WHO ADMINISTERED MEDICATION. THERE WERE NO COMPLICATIONS FROM THE INCIDENT, AND THE CHILD IS DOING WELL NOW. KAZ USA, INC. HAD REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.