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

Model Number VWM845

Device Problem Use of Device Problem (1670)

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

Event Date 01/25/2019

Event Type  Injury  

Manufacturer Narrative

Kaz usa, inc.Has requested that the product be returned for testing, but the item has not yet been received.

Event Description

A consumer called and stated that their infant child burns from the hot water that was spilled out of their warm mist humidifier.It was stated that the child pulled on the product's electrical cord which pulled the unit off of their night stand pulled it down on himself, and that is when the injuries occurred.The child received medical treatment at a hospital for a second degree burns on his back, shoulder, chest, and face, and he also required follow up care for his injuries.The instructions for proper use have very clear warnings that state, "warning : keep out of reach of children.This product produces hot steam and should be placed in an area not accessible to children or pets, with the power cord out of reach".Kaz usa, inc.Has requested that the product be returned for testing, but it has not yet been received.

• Brand Name: VICKS
• Type of Device: WARM MIST HUMIDIFIER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough 01752
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough 01752 ; 5084907236
• MDR Report Key: 8417224
• MDR Text Key: 138692418
• Report Number: 1314800-2019-00016
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: VWM845
• Device Lot Number: 16218
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 12 MO