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

Model Number V745A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 02/01/2014

Event Type  Other  

Event Description

Kaz usa received a complaint from the consumer stating that her humidifier was leaking, and the hot water caused a burn on her foot.She states that she received medical attention for a second degree burn.The owner's manual warns against coming in close contact with the unit as it produces steam.

• Brand Name: VICKS
• Type of Device: HUMIDIFIER
• 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: 3713704
• MDR Text Key: 4251321
• Report Number: 1314800-2014-00023
• Device Sequence Number: 1
• Product Code: KFZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V745A
• 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