BRAUN
Received Feb 7, 2025
Report 1314800-2025-00004 · MDR key 21333344
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT3030EELot number
UNKNOWN
Product problems
- False Negative Result
- False Negative Result
Patient
NA · Prefer Not To Disclose
- 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 RETAILER REPORTED THAT A CONSUMER'S THERMOMETER HAD ALLEGEDLY GIVEN A FALSE NEGATIVE READING ON HER CHILD. THE DEVICE ALLEGEDLY GAVE A READING OF 36.8°. THE CHILD EXPERIENCED A FEBRILE SEIZURE, THOUGH THE EXACT TIMING OF THE EVENT IS UNCLEAR. THE CHILD WAS ADMITTED INTO THE HOSPITAL FOR 5 DAYS. THE CONSUMER STATES THAT THE CHILD'S ACTUAL TEMPERATURE WAS 39°C, BUT IT IS UNKNOWN WHETHER THIS WAS CONFIRMED USING A MEDICAL-GRADE THERMOMETER. NO DETAILS WERE PROVIDED ABOUT THE CHILD'S DIAGNOSIS OR CURRENT CONDITION. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.
Description of Event or Problem
A RETAILER REPORTED THAT A CONSUMER'S THERMOMETER HAD ALLEGEDLY GIVEN A FALSE NEGATIVE READING ON HER CHILD. THE DEVICE ALLEGEDLY GAVE A READING OF 36.8°. THE CHILD EXPERIENCED A FEBRILE SEIZURE, THOUGH THE EXACT TIMING OF THE EVENT IS UNCLEAR. THE CHILD WAS ADMITTED INTO THE HOSPITAL FOR 5 DAYS. THE CONSUMER STATES THAT THE CHILD'S ACTUAL TEMPERATURE WAS 39°C, BUT IT IS UNKNOWN WHETHER THIS WAS CONFIRMED USING A MEDICAL-GRADE THERMOMETER. NO DETAILS WERE PROVIDED ABOUT THE CHILD'S DIAGNOSIS OR CURRENT CONDITION.