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

Model Number V745A-VV1

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

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

Event Date 11/14/2023

Event Type  Injury  

Event Description

A consumer reported that his five year old daughter received second degree burns on her left side, neck, and chest from hot water that spilled out of their vicks warm mist humidifier during use.The unit was being used in the child's bedroom and placed on a dresser.He stated his child tried to pull the unit closer to her face and overturned the unit, and the injury occurred.Treatment and follow up care at a burn center was sought for these injuries.The instructions for proper use have 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 also securely out of reach.".

• Brand Name: VICKS
• Type of Device: WARM MIST HUMIDIFIER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01752
• Manufacturer (Section G): KUO TONG ELECTRICAL TECHNOLOGY; no.442,yongping road,; xiufeng village liangjing town; huizhou city, guangdong 51626 5; CH 516265
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 18221318
• MDR Text Key: 329163875
• Report Number: 1314800-2023-00016
• Device Sequence Number: 1
• Product Code: KFZ
• UDI-Device Identifier: 00328785207453
• UDI-Public: 00328785207453
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V745A-VV1
• Device Lot Number: 27017KUO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2023
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2017
• 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: 5 YR
• Patient Sex: Female