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

Model Number IRT3030WE

Device Problems False Negative Result (1225); Use of Device Problem (1670); Patient Device Interaction Problem (4001)

Patient Problems Asthma (1726); Fever (1858)

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

A consumer reported that their thermometer had given false negative readings on her daughter, and that the alleged inaccurate readings may have delayed seeking medical attention.The device allegedly was reading 2.2°c lower than what was measured by paramedics, where a reading of 39.4°c was obtained.The patient was transported to a hospital and treated for a fever, chest infection, and exasperation of asthma.There were no complications from this incident, and the child is doing well now.Kaz usa, inc.Has requested that the device be returned to our company for testing.

Event Description

A consumer reported that their thermometer had given false negative readings on her daughter, and that the alleged inaccurate readings may have delayed seeking medical attention.The device allegedly was reading 2.2°c lower than what was measured by paramedics, where a reading of 39.4°c was obtained.The patient was transported to a hospital and treated for a fever, chest infection, and exasperation of asthma.There were no complications from this incident, and the child is doing well now.

• 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: 13041130
• MDR Text Key: 284656912
• Report Number: 1314800-2021-00030
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161933
• 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,Followup
• Report Date: 03/15/2022

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: 18616FAM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/19/2021
• Supplement Dates Manufacturer Received: 11/30/2021
• Supplement Dates FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2016
• 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): Other; Required Intervention
• Patient Age: 3 YR
• Patient Sex: Female