MalfunctionFLL
BRAUN
Received Apr 2, 2025
Report 1314800-2025-00012 · MDR key 21759058
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT6520MNLAProduct problems
- False Negative Result
- False Negative Result
Patient
28 DA · Unknown
- Fever
- Fever
Narrative
Description of Event or Problem
A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER FOUR-WEEK-OLD CHILD. THE DEVICE ALLEGEDLY GAVE A READING OF 34.3°C, AND A TEMPERATURE MEASUREMENT OF 37.1°C WAS LATER CONFIRMED BY A DOCTOR. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL. 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.