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

Model Number IRT3030WE

Device Problem False Negative Result (1225)

Patient Problem Fever (1858)

Event Date 03/19/2024

Event Type  malfunction  

Manufacturer Narrative

Kaz usa, inc.Has requested that the product be returned to our company for testing, but it has not yet been received.

Event Description

Consumer claimed that the device gave inaccurate measurements (too low).Since the consumer did not provide more information despite our request we do not have information on the age/gender of the patient involved.The customer is claiming that the device was not taking any measurement higher than 34.8°c / 34.9°c.This was even after changing the batteries to reset the device.The consumer went to the doctor (for him/her or a child) where a reading up to 38.1°c was allegedly confirmed.It is unknown if the consumer took a measurement the same day with the thermometer resulting in a potential false negative).No information was provided on the diagnosis or current status of the patient.The only known information provided was that a fever was confirmed by a medical professional, and our device was giving false negative readings.Kaz usa, inc.Has requested that the product be returned to our company for testing.

• Brand Name: BRAUN
• Type of Device: EAR THERMOMETER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01568
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 19082084
• MDR Text Key: 340577978
• Report Number: 1314800-2024-00009
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K161933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRT3030WE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention; Other
• Patient Sex: Unknown