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

Model Number NTF3000USV1

Device Problems False Negative Result (1225); Use of Device Problem (1670); Human-Device Interface Problem (2949); Patient Device Interaction Problem (4001)

Patient Problem Fever (1858)

Event Date 01/01/2023

Event Type  malfunction  

Event 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.

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 308617178
• Report Number: 1314800-2023-00002
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00328785000306
• UDI-Public: 00328785000306
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NTF3000USV1
• Device Lot Number: 17420TAV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 13 MO
• Patient Sex: Female