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

Model Number	IRT6520
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Fever (1858)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A hospital reported that the ear thermometer allegedly provided a low temperature reading for a pediatric patient.The child's temperature was reportedly measured at 37.2°c.A subsequent measurement using a mercury thermometer allegedly showed a temperature of 39.7°c, indicating the presence of a fever.No additional information was provided regarding the patient's diagnosis or clinical outcome.The only information available is that a temperature discrepancy occurred, and the device was reported to have given a low reading.Kaz usa, inc.Has requested that the product be returned to our company for testing.

• 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; marlborough, MA 01752 ; 5084907247
• MDR Report Key: 24126613
• Report Number: 1314800-2026-00003
• Device Sequence Number: 9371623
• Product Code: FLL
• UDI-Device Identifier: 00328785001914
• UDI-Public: 00328785001914
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

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
• Operator of Device: Health Professional
• Device Model Number: IRT6520
• Device Lot Number: 35322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2022
• 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: Other
• Patient Age: 6 YR
• Patient Sex: Female