MalfunctionFLL
BRAUN
Received Apr 16, 2025
Report 1314800-2025-00014 · MDR key 21852780
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT6500USLot number
12021
Product problems
- False Negative Result
- False Negative Result
Patient
NA · 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 HIS THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HIS SON. THE DEVICE ALLEGEDLY GAVE CONSISTENT READINGS OF 96.7°F, AND A FEVER OF 101.0°F WAS LATER CONFIRMED BY A DOCTOR. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.