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

Model Number BFH175US

Device Problems False Negative Result (1225); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 07/07/2021

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 their thermometer had given false negative readings on herself.The device allegedly always gave readings around 95°f, she stated that the unit was reading 3.1°f lower than what was later measured by a doctor, where a reading of 98.1°f was obtained.There were no complications from this incident, and the patient is doing well now.Kaz usa, inc.Has requested that the device 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: 12217370
• MDR Text Key: 263164471
• Report Number: 1314800-2021-00013
• 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: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• 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: 30820TAV
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other