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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAZ USA, INC. VICKS; THERMOMETER
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KAZ USA, INC. VICKS; THERMOMETER Back to Search Results
Model Number V912
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Fever (1858)
Event Date 02/01/2014
Event Type  Other  
Event Description
The consumer reported her thermometer was widely ranging results.It was alleged that at one point the device was reading in the normal range despite the child having a fever.The consumer took her child to the doctor where his temperature was taken and it was confirmed they had fever.The varying readings may have caused a delay in medical attention.There were no complications from the delay, and the child is doing fine.
 
Manufacturer Narrative
This is within the 0.4 degree fahrenheit for tolerance.These are passing results.The alleged malfunction could not be duplicated in testing, and there were no defects found in the returned product.
 
Event Description
The consumer reported her thermometer was widely ranging results.It was alleged that at one point the device was reading in the normal range despite the child having a fever.The consumer took her child to the doctor where his temperature was taken and it was confirmed they had fever.The varying readings may have caused a delay in medical attention.There were no complications from the delay, and the child is doing fine.
 
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Brand Name
VICKS
Type of Device
THERMOMETER
Manufacturer (Section D)
KAZ USA, INC.
250 turnpike road
southborough MA 01772
Manufacturer Contact
sonja wilkinson
250 turnpike road
southborough, MA 01772
5084907136
MDR Report Key3683343
MDR Text Key4262016
Report Number1314800-2014-00018
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,consumer
Reporter Occupation Not Applicable
Type of Report Initial,Followup
Report Date 03/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberV912
Device Lot Number29512
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/02/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received02/26/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2012
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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