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

Model Number	NTF3000USV1
Medical Device Problem Codes	False Negative Result (1225); Use of Device Problem (1670); Human-Device Interface Problem (2949); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fever (1858)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A consumer reported that her thermometer had allegedly given false negative readings on her infant child.The device allegedly gave a reading of 97.0°f, and a fever of 100.7°f was later confirmed by a doctor.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.
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 her thermometer had allegedly given false negative readings on her infant child.The device allegedly gave a reading of 97.0°f, and a fever of 100.7°f was later confirmed by a doctor.There were no complications from this incident, and the patient is doing well now.
Event or Problem Description
A consumer reported that her thermometer had allegedly given false negative readings on her infant child.The device allegedly gave a reading of 97.0°f, and a fever of 100.7°f was later confirmed by a doctor.There were no complications from this incident, and the patient is doing well now.
Additional Manufacturer Narrative
Correction made in section b.6 there was a typographical error in the original supplemental report.See the attached photograph as evidence (taken on (b)(6) 2023).

• Brand Name: BRAUN
• Common Device Name: FOREHEAD 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: 16280323
• Report Number: 1314800-2023-00002
• Device Sequence Number: 6522684
• Product Code: FLL
• UDI-Device Identifier: 00328785000306
• UDI-Public: 00328785000306
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K163516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2023

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: Lay User/Patient
• Device Model Number: NTF3000USV1
• Device Lot Number: 17420TAV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 01/05/2023; 01/05/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 03/01/2023; 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2020
• 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: 13 MO
• Patient Sex: Female