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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 BFH175US
Medical Device Problem Codes False Negative Result (1225); Defective Device (2588)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 07/07/2021
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 their thermometer had given false negative readings on herself.The device allegedly always gave readings around 95°f, she stated that the unit was reading 3.1°f lower than what was later measured by a doctor, where a reading of 98.1°f was obtained.There were no complications from this incident, and the patient is doing well now.Kaz usa, inc.Has requested that the device 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 01752
MDR Report Key12217370
Report Number1314800-2021-00013
Device Sequence Number17159306
Product Code FLL
UDI-Device Identifier00328785001679
UDI-Public00328785001679
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K181015
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/30/2021
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 NumberBFH175US
Device Lot Number30820TAV
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/08/2021
Initial Report FDA Received Date07/23/2021
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;
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