BRAUN
Received Jan 3, 2026 · Event occurred Nov 25, 2025
Report 1314800-2026-00002 · MDR key 23953074
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT6520MNLALot number
19324KTC
Product problems
- False Negative Result
Patient
24 MO · Unknown
- Fever
Narrative
Description of Event or Problem
A CONSUMER REPORTED THAT HER THERMOMETER ALLEGEDLY PROVIDED INCONSISTENT AND INACCURATE READINGS ON HER 2 YEAR OLD CHILD. THE DEVICE ALLEGEDLY DISPLAYED A TEMPERATURE OF 38.5°C. DUE TO THE CHILD'S CONDITION, AN AMBULANCE WAS REPORTEDLY CALLED. A HEALTHCARE PROFESSIONAL MEASURED A TEMPERATURE OF 40.3°C. THE CHILD WAS LATER DIAGNOSED WITH CROUP AND TREATED WITH STEROIDS. THE CURRENT HEALTH STATUS OF THE PATIENT IS REPORTED AS IMPROVING. KAZ USA, INC. HAS REQUESTED THAT THE DEVICE 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.