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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 IRT6020CA
Device Problems False Negative Result (1225); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Fever (1858)
Event Type  malfunction  
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 her thermometer had allegedly given false negative readings on her infant son.The device allegedly gave a reading that was 3.8°f lower than what was later measured at the emergency room.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.
 
Event Description
A consumer reported that her thermometer had allegedly given false negative readings on her infant son.The device allegedly gave a reading that was 3.8°f lower than what was later measured at the emergency room.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
MDR Report Key10052853
MDR Text Key191267441
Report Number1314800-2020-00024
Device Sequence Number1
Product Code FLL
UDI-Device Identifier00328785000092
UDI-Public00328785000092
Combination Product (y/n)N
PMA/PMN Number
K103800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 06/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberIRT6020CA
Device Catalogue NumberIRT6020US
Device Lot Number30618K00779
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2020
Date Manufacturer Received04/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age10 MO
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