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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 BNT400CA
Device Problems False Negative Result (1225); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Fever (1858)
Event Date 09/25/2019
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 her thermometer had allegedly given false negative readings on her infant son.The device allegedly gave readings that were 3.6°f lower than what was measured at a later time at the hospital where a fever and an ear infection were confirmed.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 readings that were 3.6°f lower than what was measured at a later time at the hospital where a fever and an ear infection were confirmed.There were no complications from this incident, and the patient is doing well now.
 
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Brand Name
BRAUN
Type of Device
FOREHEAD THERMOMETER
Manufacturer (Section D)
KAZ USA, INC., A HELEN OF TROY COMPANY
marlborough MA 01752
MDR Report Key9232745
MDR Text Key191270108
Report Number1314800-2019-00048
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
PMA/PMN Number
K181242
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 11/15/2019
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
Device Operator Lay User/Patient
Device Model NumberBNT400CA
Device Lot Number35418TAV
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2019
Initial Date Manufacturer Received 09/27/2019
Initial Date FDA Received10/24/2019
Supplement Dates Manufacturer Received09/27/2019
Supplement Dates FDA Received11/15/2019
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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