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

Model Number	BNT300
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Codes	Fever (1858); Convulsion/Seizure (4406)
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that their thermometer had allegedly provided a false negative reading on their granddaughter, who has a history of febrile seizures.The device allegedly displayed a temperature of 100°f, and the child subsequently experienced a febrile seizure.The child was taken to the emergency room, where a high fever was allegedly confirmed.No additional medical details or patient outcome were provided.

• Brand Name: BRAUN
• Common Device Name: FOREHEAD 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: 23503995
• Report Number: 1314800-2025-00030
• Device Sequence Number: 8993584
• Product Code: FLL
• UDI-Device Identifier: 00328785003925
• UDI-Public: 00328785003925
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K181242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

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: BNT300
• Device Lot Number: 07722TAV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2022
• 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: Required Intervention; Other
• Patient Sex: Female