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

Model Number NTF-3000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fever (1858)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

Kaz usa, inc.Has requested that the products be returned to our company for testing, but they have not yet been received.

Event Description

A consumer reported that she has two thermometers which had allegedly given false negative readings on her son.The devices allegedly consistently gave readings that were 3.9 f degrees lower than the patients actual temperature.The child was taken to see a pediatrician where a fever was confirmed.It was also alleged that a similar incident occurred with her three year old earlier that week.There were no complications from either incident, no adverse event occurred, and both patients are doing well now.Kaz usa, inc.Has requested that the products 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: 7049677
• MDR Text Key: 93445870
• Report Number: 1314800-2017-00044
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K134043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: NTF-3000
• Device Lot Number: 02515TAV, 17414TAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2015
• 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: 12 MO