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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY BRAUN; FOREHEAD THERMOMETER
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KAZ USA, INC., A HELEN OF TROY COMPANY BRAUN; FOREHEAD THERMOMETER Back to Search Results
Model Number BFH125US
Medical Device Problem Codes False Negative Result (1225); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Fever (1858)
Date of Event 04/06/2020
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 herself.The device allegedly gave readings that were 3.9°f lower than what was later measured by their doctor.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.
 
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Brand Name
BRAUN
Common Device Name
FOREHEAD THERMOMETER
Manufacturer (Section D)
KAZ USA, INC., A HELEN OF TROY COMPANY
marlborough, ma
MDR Report Key10065241
Report Number1314800-2020-00025
Device Sequence Number777421
Product Code FLL
UDI-Device Identifier00328785002188
UDI-Public00328785002188
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K033820
Number of Events Summarized1
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) 05/18/2020
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 NumberBFH125US
Device Lot Number26318ONB
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/21/2020
Initial Report FDA Received Date05/18/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Required Intervention;
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