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

Model Number	IRT6020CA
Medical Device Problem Codes	False Negative Result (1225); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fever (1858)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A consumer reported that her thermometer had allegedly given false negative readings on her infant son.The device allegedly gave a reading that was 3.8°f lower than what was later measured at the emergency room.There were no complications from this incident, and the patient is doing well now.Kaz usa, inc.Has requested that the product be returned to our company for testing.
Event or Problem Description
A consumer reported that her thermometer had allegedly given false negative readings on her infant son.The device allegedly gave a reading that was 3.8°f lower than what was later measured at the emergency room.There were no complications from this incident, and the patient is doing well now.

• Brand Name: BRAUN
• Common Device Name: EAR THERMOMETER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough, ma
• MDR Report Key: 10052853
• Report Number: 1314800-2020-00024
• Device Sequence Number: 908492
• Product Code: FLL
• UDI-Device Identifier: 00328785000092
• UDI-Public: 00328785000092
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K103800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: IRT6020CA
• Device Catalogue Number: IRT6020US
• Device Lot Number: 30618K00779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 10 MO