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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
Device Problems False Negative Result (1225); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Fever (1858)
Event Date 12/04/2019
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 his thermometer had allegedly given false negative readings on her infant.The device allegedly gave a reading that was 3.8°f lower than what was later measured by a 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.
 
Event Description
A consumer reported that his thermometer had allegedly given false negative readings on her infant.The device allegedly gave a reading that was 3.8°f lower than what was later measured by a doctor.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
MDR Report Key9586793
MDR Text Key191268894
Report Number1314800-2020-00007
Device Sequence Number1
Product Code FLL
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 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberIRT6500
Device Lot Number02219K31241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2020
Date Manufacturer Received12/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age12 MO
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