BRAUN
Received Aug 30, 2024 · Event occurred Aug 1, 2024
Report 1314800-2024-00018 · MDR key 20108720
Device
Generic name
Forehead Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
BNT400CALot number
01322
Product problems
- False Negative Result
- False Negative Result
Patient
7 YR · Male
- Fever
- Viral Infection
- Fever
- Viral Infection
Narrative
Description of Event or Problem
A CONSUMER REPORTED THAT THEIR THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER 7-YEAR-OLD SON, WHICH DELAYED THEM SEEKING MEDICAL ATTENTION. THE DEVICE ALLEGEDLY GAVE A READINGS BETWEEN 34°C AND 35.5°C, AND A FEVER OF 40.1°C WAS LATER MEASURED AT A DOCTOR'S OFFICE. THE CHILD WAS DIAGNOSED WITH STREP THROAT. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.
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.