BRAUN
Received Feb 27, 2025
Report 1314800-2025-00006 · MDR key 21485372
Device
Generic name
Ear Thermometer
Manufacturer
Kaz Usa, Inc., A Helen Of Troy CompanyModel number
IRT6525WELot number
17424TEQ
Product problems
- False Negative Result
- False Negative Result
Patient
11 MO · Prefer Not To Disclose
- Bronchitis
- Fever
- Ear infection
- Bronchitis
- Fever
- Ear infection
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 PHARMACY REPORTED THAT A CONSUMER'S THERMOMETER ALLEGEDLY PROVIDED INACCURATE READINGS, SHOWING A TEMPERATURE OF 35°C FOR EVERY FAMILY MEMBER, INCLUDING THEIR 11-MONTH-OLD CHILD. THE CHILD WAS LATER TAKEN TO THE HOSPITAL, AND A FEVER OF 40.9°C WAS RECORDED. THE CHILD WAS DIAGNOSED WITH BRONCHITIS AND A MIDDLE EAR INFECTION. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.