MAUDE Adverse Event Report: KAZ INC VICKS; THERMOMETER

Model Number V977

Device Problem Low Test Results (2458)

Patient Problem No Code Available (3191)

Event Date 02/01/2014

Event Type  Other  

Event Description

The consumer reported her thermometer was giving a false low reading.The device was reading in a 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 child is doing fine.

• Brand Name: VICKS
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ INC; 250 turnpike road; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike road; southborough, MA 01772 ; 5084907236
• MDR Report Key: 3688146
• MDR Text Key: 4243137
• Report Number: 1314800-2014-00013
• 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: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2014
• 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: 07/09/2013
• 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
• Patient Age: 9 MO