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

Model Number BFH175US

Device Problem False Negative Result (1225)

Patient Problem Fever (1858)

Event Date 03/07/2024

Event Type  malfunction  

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 multiple false negative readings on her infant.The device allegedly gave readings that were consistantly 4.6-4.8°f low, and a fever of 100.8°f was later confirmed by a doctor.There were no complications from this incident, and the infant is doing well now.Kaz usa, inc.Has requested that the product be returned to our company for testing.

Event Description

A consumer reported that her thermometer had allegedly given multiple false negative readings on her infant.The device allegedly gave readings that were consistantly 4.6-4.8°f low, and a fever of 100.8°f was later confirmed by a doctor.There were no complications from this incident, and the infant is doing well now.

• 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
• MDR Report Key: 19002876
• MDR Text Key: 339261995
• Report Number: 1314800-2024-00008
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00328785001679
• UDI-Public: 00328785001679
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181015
• 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
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BFH175US
• Device Lot Number: 02121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2021
• 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: 4 MO
• Patient Sex: Unknown