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

Model Number	BFH175
Medical Device Problem Codes	False Negative Result (1225); 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 his thermometer had allegedly given false negative readings on her son.The device allegedly gave a readings that were 7.5°f lower than what was later measured by their pediatrician.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 his thermometer had allegedly given false negative readings on her son.The device allegedly gave a readings that were 7.5°f lower than what was later measured by their pediatrician.There were no complications from this incident, and the patient is doing well now.

• Brand Name: BRAUN
• Common Device Name: FOREHEAD THERMOMETER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough, ma
• MDR Report Key: 9756689
• Report Number: 1314800-2020-00010
• Device Sequence Number: 2495966
• Product Code: FLL
• UDI-Device Identifier: 00328785001679
• UDI-Public: 00328785001679
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181015
• 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): 03/12/2020

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: BFH175
• Device Lot Number: 20818TAV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/12/2020
• 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