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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 IRT6500US
Device Problem False Negative Result (1225)
Patient Problem Fever (1858)
Event Type  malfunction  
Event Description
A consumer reported that their thermometer had allegedly given false negative readings on himself.The device allegedly gave a reading of 95.0°f, and a fever of 100.9°f was later measured at a doctor's office.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.
 
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 Description
A consumer reported that their thermometer had allegedly given false negative readings on himself.The device allegedly gave a reading of 95.0°f, and a fever of 100.9°f was later measured at a doctor's office.There were no complications from this incident, and the patient is doing well now.
 
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Brand Name
BRAUN
Type of Device
EAR THERMOMETER
Manufacturer (Section D)
KAZ USA, INC., A HELEN OF TROY COMPANY
marlborough MA 01752
Manufacturer Contact
sonja wilkinson
400 donald lynch boulevard
suite 300
marlborough, MA 01752
MDR Report Key19002877
MDR Text Key339559070
Report Number1314800-2024-00006
Device Sequence Number1
Product Code FLL
UDI-Device Identifier00328785000054
UDI-Public00328785000054
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberIRT6500US
Device Lot Number13221K42227
Was Device Available for Evaluation? No
Date Manufacturer Received03/11/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/12/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age27 YR
Patient SexMale
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