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

Model Number V1200

Device Problems Improper or Incorrect Procedure or Method (2017); Device Tipped Over (2589)

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

Event Date 07/01/2015

Event Type  Injury  

Event Description

A complaint was forwarded to our company by (b)(4), the licensor of the vicks brand name to kaz usa, inc.The consumer reported that their daughter had tipped the unit over, and received 2nd degree burns on her left thigh from the hot water that spilled out of the personal steam inhaler.Medical intervention was sought for her injuries.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 instructions also state that the product should only be used on a flat level surface to avoid spilling water.Kaz usa, inc.Has requested that the product be returned to our company for testing.

• Brand Name: VICKS
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): KAZ USA, INC.; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike road; southborough, MA 01772 ; 5084907236
• MDR Report Key: 4960965
• MDR Text Key: 6190672
• Report Number: 1314800-2015-00059
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V1200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 07/30/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 6 YR