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 09/14/2021

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 false negative readings on her daughter.The device allegedly gave readings that were 3-4°f lower than was later measured by a doctor.There were no complications from this incident, and the patient is doing well now.Kaz usa, inc.Had requested that the product be returned to our company for testing.

• 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: 12638535
• MDR Text Key: 278402933
• Report Number: 1314800-2021-00017
• 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: 10/14/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: BFH175US
• Device Lot Number: 11820TAV
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2020
• 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; Required Intervention
• Patient Age: 18 MO