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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAZ, INC. BRAUN; THERMOMETER

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KAZ, INC. BRAUN; THERMOMETER Back to Search Results
Model Number FHT1000
Device Problem False Negative Result (1225)
Patient Problem Fever (1858)
Event Date 03/01/2015
Event Type  Other  
Event Description
The consumer reported their thermometer was giving false negative reading on their son.The device allegedly read 5-6 degrees fahrenheit lower than the child's actual temperature.The child was brought to a hospital, where it was confirmed that he had a fever.There was not adverse event reported, and there were no complications due to the product malfunction.The patient is doing fine now.Kaz usa, inc.Has requested that the product be returned for testing.
 
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Brand Name
BRAUN
Type of Device
THERMOMETER
Manufacturer (Section D)
KAZ, INC.
250 turnpike road
southborough MA 01772
Manufacturer Contact
sonja wilkinson
250 turnpike road
southborough, MA 01772
5084907236
MDR Report Key4731486
MDR Text Key5740521
Report Number1314800-2015-00028
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K033820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 04/22/2015
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 NumberFHT1000
Device Lot Number23914ONB
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/31/2015
Initial Date FDA Received04/22/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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