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

Model Number IRT6500

Device Problems False Negative Result (1225); Insufficient Information (3190)

Patient Problem Fever (1858)

Event Date 02/28/2020

Event Type  malfunction  

Manufacturer Narrative

Kaz usa, inc.Has requested that the product be returned to our company for testing, but the consumer stated that they had already discarded the device, and it could not be retrieved.

Event Description

A consumer reported that her thermometer had allegedly given false negative readings on her daughter.The device allegedly gave a reading that was 5.8 - 6.8°f lower than what was later measured at the hospital, where a high fever was recorded.There were no complications from this incident, and the patient is doing well now.Kaz usa, inc.Had requested that the product be returned to our company for testing, but the consumer stated that they had already discarded the device.

• Brand Name: BRAUN
• Type of Device: INFRARED EAR THERMOMETER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough, ma
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough, ma ; 4907236
• MDR Report Key: 10114324
• MDR Text Key: 195296397
• Report Number: 1314800-2020-00026
• 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
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRT6500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2019
• 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: 24 MO