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

Model Number	V745A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	12/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer called and stated that he received second degree burns on his leg from the hot water that was leaking out of their humidifier while he was sleeping.The consumer stated that he is a doctor, and that he was treating the injury himself.The instructions for proper use have very clear warnings that states, "the appliance should always be placed on a firm, flat, waterproof surface at least four feet away from bedside, twelve inches from the wall and out of reach of patient, children and pets." it also states, "be sure the removable water tray and cooling chamber are in place and the cooling chamber interlock is engaged.".

• Brand Name: VICKS
• Common Device Name: WARM MIST HUMIDIFIER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01752
• MDR Report Key: 8277856
• Report Number: 1314800-2019-00011
• Device Sequence Number: 1349792
• Product Code: KFZ
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2019

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
• Operator of Device: Health Professional
• Device Model Number: V745A
• Device Lot Number: 28917KUO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2019
• Initial Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention