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

Model Number V1200

Device Problems Device Slipped (1584); Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 11/04/2014

Event Type  Other  

Event Description

A complaint was received from the fda's medwatch program, (b)(4).The complaint alleged that a consumer received burns while using a personal steam inhaler."my wife moved the item and the container with hot water, slipped off and spilled scalding hot water on her." it is unknown whether 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 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.; 250 turnpike rd.; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike rd.; southborough, MA 01772 ; 5084907236
• MDR Report Key: 4756300
• MDR Text Key: 5792631
• Report Number: 1314800-2015-00030
• Device Sequence Number: 1
• Product Code: KFZ
• Combination Product (y/n): N
• Reporter Country Code: AA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/01/2015

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: 04/08/2015
• Initial Date FDA Received: 05/01/2015
• 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): Other