BRAUN
Received Aug 1, 2024 · Event occurred Jun 24, 2024
Report 1314800-2024-00014 · MDR key 19887263
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT3030WELot number
24923FAM
Product problems
- False Negative Result
- False Negative Result
Patient
24 MO · Male
- Fever
- Viral Infection
- Convulsion/Seizure
- Fever
- Viral Infection
- 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 HER THERMOMETER HAD ALLEGEDLY GIVEN A FALSE NEGATIVE READING ON HER SON. THE DEVICE ALLEGEDLY GAVE REPEATED READINGS OF 37°C. THE CHILD LATER HAD A FEBRILE SEIZURE AND WAS TAKEN TO A HOSPITAL WHERE A FEVER OF 40°C AND THE PRESENCE OF A VIRUS WAS CONFIRMED. 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.