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

Model Number	IRT6525
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Codes	Fever (1858); Convulsion/Seizure (4406)
Type of Reportable Event	Serious Injury
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 consumer reported that their thermometer had allegedly given false negative readings on their infant son.The device allegedly gave readings ranging from 36.5 to 38.9°c.The child later had a febrile seizure and was taken to the hospital where a fever of 38.0°c was confirmed.The child was admitted to the hospital for three days.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.

• Brand Name: BRAUN
• Common Device Name: EAR THERMOMETER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; 400 donald lynch boulevard; suite 300; marlborough MA 01752
• Manufacturer Contact: bethany lee ; 400 donald lynch boulevard suite 300; marlborough, MA 01752
• MDR Report Key: 21129508
• Report Number: 1314800-2024-00028
• Device Sequence Number: 20699121
• Product Code: FLL
• UDI-Device Identifier: 00328785001914
• UDI-Public: (01)00328785001914
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2025

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: Lay User/Patient
• Device Model Number: IRT6525
• Device Lot Number: 05724K40026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2024
• 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; Hospitalization; Other
• Patient Age: 21 MO
• Patient Sex: Male