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

Model Number	VWM845
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Viral Infection (2248); Insufficient Information (4580)
Type of Reportable Event	Death
Event or Problem Description
A consumer reported that her husband had been using a vicks warm mist humidifier in conjunction with vicks vaposteam and vicks vapopads in the spring of 2020 while he was diagnosed with covid-19.She stated that her husband passed away due to complications related to covid-19 infection, and alleges that one of the doctors who had been treating him believes that the use of vaposteam may have contributed to his respiratory issues and decreased his chance of recovering.Kaz usa, inc.Has requested that the product be returned to our company for testing, but the woman stated that she had since gifted the humidifier to a family friend and was unsure whether she could get it back.
Additional Manufacturer Narrative
Kaz usa, inc.Has requested that the product be returned to our company for testing, but it has not yet been received.

• Brand Name: VICKS
• Common Device Name: 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: 13388823
• Report Number: 1314800-2022-00005
• Device Sequence Number: 1817475
• Product Code: KFZ
• UDI-Device Identifier: 00328785001365
• UDI-Public: 00328785001365
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2022

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: Lay User/Patient
• Device Model Number: VWM845
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male