BRAUN
Received May 17, 2025 · Event occurred Apr 17, 2025
Report 1314800-2025-00018 · MDR key 22041194
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT6520CALot number
31324K30747
Product problems
- False Negative Result
- False Negative Result
Patient
3 YR · Male
- 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 HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER 3-YEAR-OLD SON. THE DEVICE ALLEGEDLY GAVE READINGS OF 37.5°C, AND A FEVER OF 39.5°C WAS LATER MEASURED AT AN EMERGENCY ROOM. THE CHILD WAS DIAGNOSED WITH AN INFECTION AND GIVEN ANTIBIOTICS. THERE WERE NO REPORTED COMPLICATIONS FROM THIS INCIDENT. KAZ USA, INC. HAS REQUESTED THAT THE DEVICE BE RETURNED TO OUR COMPANY FOR TESTING.