BRAUN
Received Jan 10, 2025
Report 1314800-2024-00028 · MDR key 21129508
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT6525Lot number
05724K40026
Product problems
- False Negative Result
- False Negative Result
Patient
21 MO · Male
- Fever
- Convulsion/Seizure
- Fever
- Convulsion/Seizure
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 THEIR THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON THEIR INFANT SON. THE DEVICE ALLEGEDLY GAVE READINGS RANGING FROM 36.5 TO 38.9°C. THE CHILD LATER HAD A FEBRILE SEIZURE AND WAS TAKEN TO THE HOSPITAL WHERE A FEVER OF 38.0°C WAS CONFIRMED. THE CHILD WAS ADMITTED TO THE HOSPITAL FOR THREE DAYS. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.