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

Model Number FHT1000

Device Problem Calibration Error (1078)

Patient Problem Fever (1858)

Event Type  malfunction  

Event Description

The consumer reported their thermometer was giving (b)(6) readings on their child.The device allegedly was reading 4.1 degrees lower than the patient's actual temperature.The child was seen by a doctor where it was confirmed that she had a fever.There were no complications from this incident, and the patient is doing well.Kaz usa, inc.Has requested that the product be returned to our company for testing.

• Brand Name: BRAUN
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; 400 donald lynch blvd.; suite 300; marlborough MA 01752
• Manufacturer (Section G): KAZ USA, INC., A HELEN OF TROY COMPANY
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 5790430
• MDR Text Key: 49565588
• Report Number: 1314800-2016-00035
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033820
• 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: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: FHT1000
• Device Lot Number: 08913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2013
• 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