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

Model Number IRT3030US

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

Patient Problem Fever (1858)

Event Date 05/26/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A consumer reported that their thermometer had given false negative readings on her son.The device allegedly gave readings that were 3° f lower than what was later measured at an urgent care facility.She stated that the device then read 5.4° f lower after returning from the urgent care clinic.There were no complications from this incident, and the patient is doing well now.Kaz usa, inc.Has requested that the device 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 01752
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 12031289
• MDR Text Key: 257126821
• Report Number: 1314800-2021-00009
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00032875000146
• UDI-Public: 0032875000146
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 06/21/2021

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: IRT3030US
• Device Lot Number: 21317
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 2.5 YR