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

Model Number	BFH150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	04/12/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
A second thermometer was returned to our company by the same consumer.The second device was not related to this adverse event, and was a different model.The consumer stated that she believed that the second device was also giving false negative readings.Both devices were found to be within the 0.4°f tolerance for accuracy when tested in our lab.
Event or Problem Description
A consumer reported that her thermometer had allegedly given false negative readings on her step-mother.It was alleged that the device gave readings that were 2.5 - 5°f lower than what was later measured in an ambulance.The patient was admitted into a hospital and tested positive for covid-19.She passed away 2 days after being admitted into the hospital.It was alleged that the false negative readings given by the device may have caused a delay in medical treatment, but that she did not feel well for several days prior to calling an ambulance.It was stated that the patient had pre-existing medical conditions which put her at high risk, and also stated that catching the fever earlier with a working thermometer would likely not have made a difference but it would have been nice to know that she had a fever.

• Brand Name: BRAUN
• Common Device Name: FOREHEAD THERMOMETER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough, ma
• MDR Report Key: 10423325
• Report Number: 1314800-2020-00033
• Device Sequence Number: 2942643
• Product Code: FLL
• UDI-Device Identifier: 00328785000559
• UDI-Public: 00328785000559
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K134043
• 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
• Report Date (Section B): 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: BFH150
• Device Lot Number: 20117TAV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/18/2020
• 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: Death