MAUDE Adverse Event Report: KAZ USA INC. VICKS; THERMOMETER

Model Number V977

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2014

Event Type  Other  

Event Description

The consumer reported her thermometer was giving a false negative reading.The device was reading in the normal range despite the infant having a fever.The consumer took her child to the doctor where his temperature was taken and it was confirmed they had fever.The inaccurate reading may have caused a delay in medical attention.There were no complications from the delay, and the infant is doing fine.

• Brand Name: VICKS
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ USA INC.; 250 turnpike road; southborough NC 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike road; southborough, NC 01772 ; 5084907236
• MDR Report Key: 3683335
• MDR Text Key: 21313765
• Report Number: 1314800-2014-00016
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: V977
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2014
• 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 Number: 1
• Patient Outcome(s): Other