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

Model Number	BFH175US
Medical Device Problem Codes	False Negative Result (1225); Use of Device Problem (1670); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fever (1858)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A consumer reported that his thermometer had allegedly given false negative readings on his child.The device allegedly gave a reading of 96.1°f, and a fever of 99.2°f was later confirmed by a doctor.There were no complications from this incident, and the patient is doing well now.

• Brand Name: BRAUN
• Common Device Name: FOREHEAD THERMOMETER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01752
• Manufacturer (Section G): AVITA (WUJIANG) CO., LTD; no.858.jiao tong road; wujiang economic development z; wujiang city, jiangsu 21520 0; CH 215200
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 18496386
• Report Number: 1314800-2024-00001
• Device Sequence Number: 17890375
• Product Code: FLL
• UDI-Device Identifier: 00328785001679
• UDI-Public: 00328785001679
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181015
• 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): 01/11/2024

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: BFH175US
• Device Lot Number: 21820TAV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2020
• 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: Other
• Patient Age: 11 YR
• Patient Sex: Female