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

Model Number V150SGNL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/26/2017

Event Type  Injury  

Manufacturer Narrative

Kaz usa, inc.Has requested that the product be returned to our company for testing, but the unit has not been received.

Event Description

A consumer called and stated that their daughter received 1st and second degree burns from the hot steam that was coming out of their vaporizer.The child received medical treatment at an emergency room.The instructions for proper use have very clear warnings that state, "warning: keep out of reach of children.We recognize that many of our customers use vaporizers in homes with young children.Carefully supervise your children when the vaporizer is operating, especially crawling infants and toddlers.For children who can understand, please be sure to take the time to instruct them that the vaporizer is not a toy.It is a device that produces hot steam and could cause severe burns and injuries if they do not stay away from it." kaz usa, inc.Has requested that the product be returned for testing.

• Brand Name: VICKS
• Type of Device: VAPORIZER
• 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: 6356190
• MDR Text Key: 68271343
• Report Number: 1314800-2017-00005
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 02/24/2017

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: Patient Family Member or Friend
• Device Model Number: V150SGNL
• Device Lot Number: 27016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 10 YR