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

Model Number IRT-3020

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

Patient Problem Fever (1858)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

Kaz usa, inc.Has requested that the product be returned to our company for testing, but the unit has not been received.

Event Description

The consumer reported their thermometer was giving false negative readings on their child.The device allegedly was reading 5 to 7 degrees lower than the patient's actual temperature.The child was seen at a hospital where it was confirmed that he had a fever of 102.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.

Event Description

The consumer reported their thermometer was giving false negative readings on their child.The device allegedly was reading 5 to 7 degrees lower than the patient's actual temperature.The child was seen at a hospital where it was confirmed that he had a fever of 102.There were no complications from this incident, and the patient is doing well.Kaz.

• Brand Name: BRAUN
• Type of Device: EAR 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: 6039588
• MDR Text Key: 57812452
• Report Number: 1314800-2016-00054
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103097
• 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,Followup
• Report Date: 03/16/2017

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: Patient Family Member or Friend
• Device Model Number: IRT-3020
• Device Lot Number: 32415RAD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2015
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 3 YR