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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; EAR THERMOMETER
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KAZ USA, INC., A HELEN OF TROY COMPANY BRAUN; EAR THERMOMETER Back to Search Results
Model Number IRT6500
Medical Device Problem Code False Negative Result (1225)
Health Effect - Clinical Codes Fever (1858); Pneumonia (2011)
Date of Event 08/05/2021
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 was reading 5.2°f lower than what was measured by a doctor, where a reading of 102.8°f was obtained.The patient was transported to a hospital, and treated for a fever and pneumonia.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
EAR THERMOMETER
Manufacturer (Section D)
KAZ USA, INC., A HELEN OF TROY COMPANY
marlborough MA 01752
MDR Report Key12750652
Report Number1314800-2021-00021
Device Sequence Number4921152
Product Code FLL
UDI-Device Identifier00328785000054
UDI-Public00328785000054
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K103800
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) 11/03/2021
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 NumberIRT6500
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/05/2021
Initial Report FDA Received Date11/04/2021
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; Required Intervention;
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