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

Model Number V912

Device Problem Low Readings (2460)

Patient Problem No Code Available (3191)

Event Date 01/06/2014

Event Type  Other  

Event Description

The consumer reported her thermometer was allegedly reading several degrees low.The child was admitted to the emergency room for eval.The pt was released from the hospital within 4 hours with no further issues.

• 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: 3653274
• MDR Text Key: 18793739
• Report Number: 1314800-2014-00001
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043110
• 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: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2014
• 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
• Patient Age: 5 YR