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

Model Number V745A

Device Problem Use of Device Problem (1670)

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

Event Date 12/21/2018

Event Type  Injury  

Event 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
• 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: 8277856
• MDR Text Key: 134099177
• Report Number: 1314800-2019-00011
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention