BRAUN

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 35-YEAR-OLD PATIENT WHO HAD PRESENTED WITH FEVER AND DISCOMFORT. THE PATIENT MEASURED AN AXILLARY TEMPERATURE OF 39.3°C USING A SELF-PROVIDED MERCURY THERMOMETER. SUBSEQUENT MEASUREMENTS TAKEN BY NURSING STAFF USING AN EAR THERMOMETER ALLEGEDLY SHOWED A HIGHEST TEMPERATURE OF 37.6°C. THE PATIENT REQUESTED TO BE DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE PATIENT'S DIAGNOSIS OR OUTCOME. THE ONLY INFORMATION AVAILABLE IS THAT A TEMPERATURE DISCREPANCY OCCURRED, AND THE DEVICE WAS REPORTED TO HAVE GIVEN A LOW READING. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.