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

Model Number IRT6500US

Device Problem False Negative Result (1225)

Patient Problem Fever (1858)

Event Date 01/31/2023

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 her thermometer had allegedly given false negative readings on her daughter.The device allegedly gave a reading of 97.6°f, and a fever of 101.0°f was later confirmed by a doctor.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.

Event Description

A consumer reported that her thermometer had allegedly given false negative readings on her daughter.The device allegedly gave a reading of 97.6°f, and a fever of 101.0°f was later confirmed by a doctor.There were no complications from this incident, and the patient 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: 16552802
• MDR Text Key: 311668019
• Report Number: 1314800-2023-00004
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00328785000054
• UDI-Public: 00328785000054
• 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,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRT6500US
• Device Lot Number: 08620K32840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2020
• 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