MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY VICKS; HUMIDIFIER

Model Number V1200

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

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

Event Date 07/19/2016

Event Type  Injury  

Manufacturer Narrative

Kaz usa, inc.Has requested that the product be returned to our company for testing.

Event Description

A consumer reported that she received 1st and 2nd degree burns on her chest from hot water that spilled out of a personal steam inhaler when it was being moved.It is unknown whether medical intervention was sought for her injuries.The instructions for proper use have a clear warning 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., A HELEN OF TROY COMPANY; marlborough MA 01752
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 5888562
• MDR Text Key: 52509520
• Report Number: 1314800-2016-00045
• 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: Patient
• Type of Report: Initial
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V1200
• Device Lot Number: 07916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2016
• 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