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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY VICKS; THERMOMETER

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KAZ USA, INC., A HELEN OF TROY COMPANY VICKS; THERMOMETER Back to Search Results
Model Number V980
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fever (1858)
Event Date 10/14/2016
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
The consumer reported their thermometer was giving false negative readings on their infant.The device allegedly was reading 5 degrees lower than the patient's actual temperature.The patient was brought to a hospital, where it was confirmed that they had a fever.There were no complications from this incident, and the patient is doing well.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., A HELEN OF TROY COMPANY
marlborough MA 01752
Manufacturer Contact
sonja wilkinson
400 donald lynch boulevard
suite 300
marlborough, MA 01752
5084907236
MDR Report Key6112541
MDR Text Key60430539
Report Number1314800-2016-00059
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
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 11/18/2016
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 Patient Family Member or Friend
Device Model NumberV980
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/21/2016
Initial Date FDA Received11/18/2016
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
Patient Outcome(s) Other; Required Intervention;
Patient Age9 MO
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