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

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.

• 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 Key: 4731487
• MDR Text Key: 5750285
• Report Number: 1314800-2015-00029
• Device Sequence Number: 1
• Product Code: FLL
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: V980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2015
• 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 Number: 1