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

Model Number IRT-6500

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

Patient Problems Fever (1858); Seizures (2063)

Event Date 06/12/2017

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 her thermometer had allegedly given several false negative reading on their infant son.The device allegedly gave readings that were 3.2 and 3.3 degrees lower than the patients actual temperature on two several occasions.Both times the child was taken to a hospital or walk in clinic where a fever was confirmed.It was also alleged that the false negative readings may have contributed to unforeseen febrile seizures.There were no complications from these incidents, 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: 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: 6731439
• MDR Text Key: 80675445
• Report Number: 1314800-2017-00035
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103800
• 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: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: IRT-6500
• Device Lot Number: 37816KTC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention