BRAUN
Received Aug 28, 2024 · Event occurred Jul 24, 2024
Report 1314800-2024-00016 · MDR key 20086919
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT6575USLot number
22023
Product problems
- False Negative Result
- False Negative Result
Patient
5 MO · Male
- Fever
- Viral Infection
- Fever
- Viral Infection
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 FIVE-MONTH-OLD SON. THE DEVICE ALLEGEDLY GAVE READINGS OF 96°F AND 98°F. THE CHILD WAS TAKEN TO A HOSPITAL WHERE A RECTAL TEMPERATURE OF 103.6°C AND THE PRESENCE OF CORONA 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.