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

Model Number VWM845

Device Problems Use of Device Problem (1670); Patient Device Interaction Problem (4001)

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

Event Date 11/21/2022

Event Type  Injury  

Event Description

A consumer called and stated that their infant pulled on the humidifier's cord during operation, which caused the unit to spill hot water onto the child.The child received medical treatment at an emergency room for second degree burns on his neck, ear, and chest, and he also required follow up care for these 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.", as well as " the humidifier should always be placed on a firm, flat, waterproof surface at least four feet (1.2 m) away from bedside, 12 inches (30 cm) from the wall and out of reach of children and pets.Be sure the humidifier is in a stable position and the power cord is away from heated surfaces and out of the way to prevent the humidifier from being overturned." kaz usa, inc.Has requested that the product be returned to our company for testing, but the consumer stated that they no longer have the product.

Manufacturer Narrative

Kaz usa, inc.Has requested that the product be returned to our company for testing, but the consumer stated that they no longer have the device.

• Brand Name: VICKS
• Type of Device: WARM MIST 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: 15994932
• MDR Text Key: 305590089
• Report Number: 1314800-2022-00024
• Device Sequence Number: 1
• Product Code: KFZ
• UDI-Device Identifier: 10328785001362
• UDI-Public: 00328785001365
• 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: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 10 MO
• Patient Sex: Male