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

Model Number BFH175US

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

Patient Problem Fever (1858)

Event Date 12/11/2023

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 333207985
• Report Number: 1314800-2024-00001
• 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
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• 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: 21820TAV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2020
• 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): Other
• Patient Age: 11 YR
• Patient Sex: Female