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

Model Number V980

Device Problem False Negative Result (1225)

Patient Problems Fever (1858); Seizures (2063)

Event Date 11/13/2014

Event Type  Other  

Event Description

The consumer reported their thermometer was giving false negative readings on their infant.They stated the readings were fluctuating from 101.5 to 107.7 degrees fahrenheit.The infant suffered from a febrile seizure and was admitted to the hospital, where a fever of 105 degrees fahrenheit was confirmed.The current status of the patient is unknown.Kaz has requested that the product be returned to our company for analysis in our laboratory.

• Brand Name: VICKS
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ, USA INC.; 250 turnpike road; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike road; southborough, MA 01772 ; 5084907236
• MDR Report Key: 4385944
• MDR Text Key: 18893358
• Report Number: 1314800-2014-00086
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103839
• 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: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V980
• Device Lot Number: 24613AMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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: 16 MO