BRAUN
Received Jul 23, 2025
Report 1314800-2025-00021 · MDR key 22583105
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT6520BWELot number
33221K10728
Product problems
- False Negative Result
- False Negative Result
Patient
12 MO · Male
- Fever
- Fever
Narrative
Description of Event or Problem
A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER ONE-YEAR-OLD SON. THE DEVICE ALLEGEDLY GAVE A READING OF 38.1°C, AND A TEMPERATURE MEASUREMENT OF 40.5°C WAS LATER CONFIRMED BY A DOCTOR. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT.
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 ONE-YEAR-OLD SON. THE DEVICE ALLEGEDLY GAVE A READING OF 38.1°C, AND A TEMPERATURE MEASUREMENT OF 40.5°C WAS LATER CONFIRMED BY A DOCTOR. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.