BRAUN
Received Dec 4, 2024
Report 1314800-2024-00023 · MDR key 20845247
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 · Male
- 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 INFANT SON. THE DEVICE ALLEGEDLY GAVE REPEATED READINGS OF 34°C-38°C. THE CHILD LATER HAD A FEBRILE SEIZURE AND WAS ADMITTED INTO INTENSIVE CARE WHERE A FEVER OF 41°C WAS CONFIRMED. NO INFORMATION WAS PROVIDED REGARDING THEIR DIAGNOSIS OR THE CURRENT STATUS OF THE PATIENT. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.