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

Model Number IRT-4520

Device Problems Device Reprocessing Problem (1091); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fever (1858)

Event Date 07/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) has requested that the product be returned to our company for testing, but the unit has not been received.

Event Description

A consumer reported that their thermometer was giving (b)(6) readings on their two children.The device allegedly was reading 3 to 4 degrees lower than the patient's actual temperature.One of the children was at a hospital where it was confirmed that she had a fever.There were no complications from this incident, and the patient is doing well.(b)(4) has requested that the product be returned to our company for testing.

Event Description

A consumer reported that their thermometer was giving false negative readings on their two children.The device allegedly was reading 3 to 4 degrees lower than the patient's actual temperature.One of the children was at a hospital where it was confirmed that she had a fever.There were no complications from this incident, and the patient is doing well.

• Brand Name: BRAUN
• Type of Device: 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: 5986872
• MDR Text Key: 55919261
• Report Number: 1314800-2016-00052
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: IRT-4520
• Device Lot Number: 20512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2012
• 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: 10 MO