MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY BRAUN; EAR THERMOMETER

Model Number IRT4520

Device Problem False Negative Result (1225)

Patient Problem Fever (1858)

Event Date 11/18/2022

Event Type  malfunction  

Event Description

A consumer reported that his thermometer had allegedly given false negative readings on himself.The device allegedly gave multiple low readings around 94-97°f, and the patient later went to the emergency room where a fever of 101.9°f was confirmed.The patient was treated at a hospital for five days, and was later released.There were no complications from this incident, and the patient is doing better now.Kaz usa, inc.Has requested that the product be returned to our company for testing.

Manufacturer Narrative

This model has not been manufactured for at least seven years, so the device is well beyond its warranty.Kaz usa, inc.Has requested that the product be returned to our company for testing, but it has not yet been received.

• Brand Name: BRAUN
• Type of Device: EAR THERMOMETER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01752
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 15994931
• MDR Text Key: 308237490
• Report Number: 1314800-2022-00023
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRT4520
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Sex: Male