BRAUN
Received Oct 21, 2024 · Event occurred Sep 19, 2024
Report 1314800-2024-00019 · MDR key 20492526
Device
Generic name
Forehead Non-contact Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
BNT300WELot number
UNKNOWN
Product problems
- False Negative Result
- False Negative Result
Patient
4 YR · Female
- Autoimmune Disorder
- Fever
- Autoimmune Disorder
- Fever
Narrative
Description of Event or Problem
A CONSUMER REPORTED THAT THEIR THERMOMETER HAD ALLEGEDLY GIVEN MULTIPLE FALSE NEGATIVE READINGS ON THEIR 4-YEAR-OLD DAUGHTER. THE CHILD WAS RECENTLY SEEN BY A DOCTOR (FOR REASONS UNRELATED TO THE ALLEGED DEVICE MALFUNCTION), WHERE THEY COMPARED THE CONSUMER'S THERMOMETER WITH A PROFESSIONAL DEVICE. AT THIS TIME, THE BNT300 DEVICE ALLEGEDLY GAVE A READING THAT WAS 2°C LOWER THAN THE PROFESSIONAL UNIT (MODEL UNKNOWN). THE CHILD WAS DIAGNOSED WITH CROHN'S DISEASE. 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.