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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 V980
Device Problem False Negative Result (1225)
Patient Problem Fever (1858)
Event Type  malfunction  
Event Description
The consumer reported their thermometer gave a false negative reading on her son.She stated the thermometer gave a reading that was 10.7 degrees fahrenheit lower than the child's actual temperature.The child was seen by a doctor, where a fever was confirmed.There was no adverse event reported and there were no complications from this incident.The pt 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
THERMOMETER
Manufacturer (Section D)
KAZ USA, INC.
250 turnpike rd
southborough MA 01772
Manufacturer Contact
sonja wilkinson
250 turnpike rd
southborough, MA 01772
5084907236
MDR Report Key4868868
MDR Text Key6265337
Report Number1314800-2015-00051
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103839
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 06/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberV980
Device Lot Number24811ONB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received06/09/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age30 MO
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