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

Model Number V1300

Device Problems Fluid/Blood Leak (1250); Human-Device Interface Problem (2949)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Type  Other  

Event Description

A consumer called to report that a child was burned by steam inhaler.The incident allegedly occurred when the child was attempting to move the product away from herself to place on a shelf.The bottom portion of the unit detached from the top causing the water to spill.The pt required medical treatment for first and second degree burns to her buttocks.The instructions for proper use have a clear warning to never hold the unit while in operation and that the unit should not be operated by children.The product is only to be used on a flat level surface.The product involved in this incident has been requested to be returned for investigation.

• Brand Name: VICKS
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): KAZ, INC.; 250 turnpike rd; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike rd; southborough, MA 01772 ; 5084907236
• MDR Report Key: 3608247
• MDR Text Key: 17276660
• Report Number: 1314800-2013-00054
• Device Sequence Number: 1
• Product Code: KFZ
• Combination Product (y/n): N
• 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: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V1300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2013
• 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: 6 YR