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

Model Number IRT6020US

Device Problem False Negative Result (1225)

Patient Problem Fever (1858)

Event Type  malfunction  

Event Description

A consumer reported that her thermometer had allegedly given false negative readings on herself, while she was recovering from covid-19.The device allegedly gave readings that were 3.3°f lower than was measured at a doctor's office 30 minutes later.It was also stated that she believed that the unit may have also given low readings on her son previously.There were no complications from this incident, and both the patient and her child are doing well now.Kaz usa, inc.Had requested that the product be returned to our company for testing.

Manufacturer Narrative

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

• 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: 14462326
• MDR Text Key: 300329990
• Report Number: 1314800-2022-00013
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00328785000092
• UDI-Public: 00328785000092
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRT6020US
• Device Catalogue Number: IRT6020US
• Device Lot Number: 12521K34097
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• 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): Required Intervention; Other
• Patient Age: 35 YR
• Patient Sex: Female