BRAUN
Received Aug 28, 2024 · Event occurred Jul 31, 2024
Report 1314800-2024-00017 · MDR key 20086903
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT6500USLot number
01024K14720
Product problems
- False Negative Result
- False Negative Result
Patient
18 MO · Male
- Fever
- Fever
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 WAS GIVING ERROR MESSAGES, AND HAD ALLEGEDLY GIVEN A FALSE NEGATIVE READING ON HIS 18-MONTH-OLD SON. THE DEVICE ALLEGEDLY GAVE A READING OF 100°F, AND A FEVER OF 103°F WAS LATER MEASURED AT A DOCTOR'S OFFICE. 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.