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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAZ, INC. VICKS; THERMOMENTER

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KAZ, INC. VICKS; THERMOMENTER Back to Search Results
Model Number V980
Device Problem False Negative Result (1225)
Patient Problem Fever (1858)
Event Date 03/30/2015
Event Type  Other  
Event Description
The consumer reported their thermometer was giving false negative readings.They stated the thermometer was giving reading that were 3 to 4 degrees fahrenheit lower than the patients's actual temperature.The patient was seen in the emergency room, where a fever was confirmed.There was no adverse event reported, and there were no complications from this incident.The patient is doing fine now.Kaz usa, inc.Has requested that the product be returned to our company for testing.
 
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Brand Name
VICKS
Type of Device
THERMOMENTER
Manufacturer (Section D)
KAZ, INC.
250 turnpike road
southborought MA 01772
Manufacturer (Section G)
KAZ, INC.
one vapor trail
hudson NY 12534
Manufacturer Contact
one vapor trail
hudson, NY 12534
MDR Report Key4731487
MDR Text Key5750285
Report Number1314800-2015-00029
Device Sequence Number1
Product Code FLL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
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 NumberV980
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/22/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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