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

Model Number BFH175US

Device Problems False Negative Result (1225); Insufficient Information (3190)

Patient Problem Fever (1858)

Event Date 06/21/2020

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 his thermometer had allegedly given false negative readings on her mother.The device allegedly gave a readings that were 4.5°f lower than what was later measured at an emergency room.There were no complications from this incident, and the patient is doing well now.Kaz usa, inc.Has 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
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough, ma ; 4907236
• MDR Report Key: 10279722
• MDR Text Key: 199991137
• Report Number: 1314800-2020-00031
• 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: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: 10120TAV
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention