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

Model Number	IRT6575
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Codes	Fever (1858); Convulsion/Seizure (4406)
Date of Event	03/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A consumer reported that their thermometer (irt6575) allegedly provided a false negative reading when used on their 12-month-old son.The device allegedly displayed a temperature of 99.5°f, although the child was later found to have an actual fever of 105°f.The child subsequently experienced a febrile seizure, and emergency services were called.A paramedic confirmed the 105°f temperature upon arrival.The consumer stated that the thermometer had been used once previously and appeared to function properly at that time.She also mentioned that she works in the nursing field.The child's current condition was not reported.Kaz usa, inc.Has requested that the product be returned to our company for testing.
Additional Manufacturer Narrative
Kaz usa, inc.Has requested that the product be returned to our company for testing, but it has not yet been received.

• Brand Name: BRAUN
• Common Device Name: EAR THERMOMETER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01752
• Manufacturer Contact: bethany lee ; 400 donald lynch boulevard; suite 300; 5084907247
• MDR Report Key: 24918611
• Report Number: 1314800-2026-00007
• Device Sequence Number: 10420076
• Product Code: FLL
• UDI-Device Identifier: 00328785007909
• UDI-Public: 00328785007909
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K103800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IRT6575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 12 MO
• Patient Sex: Male