BRAUN
Received May 14, 2026 · Event occurred Mar 31, 2026
Report 1314800-2026-00008 · MDR key 25179027
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT6520Lot number
00521
Product problems
- False Negative Result
Patient
12 YR · Male
- 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 HOSPITAL REPORTED THAT THE EAR THERMOMETER ALLEGEDLY PROVIDED A LOW TEMPERATURE READING FOR A PEDIATRIC PATIENT. THE CHILD'S TEMPERATURE WAS REPORTEDLY MEASURED AT 36.6°C. A SUBSEQUENT MEASUREMENT USING A MERCURY THERMOMETER ALLEGEDLY SHOWED A TEMPERATURE OF 38.8°C, INDICATING THE PRESENCE OF A FEVER. ANTIPYRETIC TREATMENT WAS REPORTEDLY INITIATED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE PATIENT'S DIAGNOSIS OR CLINICAL OUTCOME. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.