BRAUN
Received Nov 19, 2024 · Event occurred Oct 10, 2024
Report 1314800-2024-00020 · MDR key 20726269
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT3030WELot number
15323FAM
Product problems
- False Negative Result
- False Negative Result
Patient
18 MO · Female
- Fever
- Convulsion/Seizure
- Fever
- Convulsion/Seizure
Narrative
Additional Manufacturer Narrative
KAZ USA, INC. HAS REQUESTED ADDITIONAL INFORMATION REGARDING THIS INCIDENT, AND ALSO 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 A FALSE NEGATIVE READING ON HER 18 MONTH OLD DAUGHTER. THE DEVICE ALLEGEDLY GAVE READINGS OF 37.6°C. THE CHILD HAD A FEBRILE SEIZURE AND THE PARAMEDICS WERE CALLED WHERE THEIR THERMOMETER CONFIRMED A FEVER OF 39.9°C. THE INVESTIGATION IS STILL ONGOING WITH THE CONSUMER, AND KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.