MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY VICKS; PERSONAL STEAM INHALER

Model Number	VIH200
Medical Device Problem Codes	Use of Device Problem (1670); Human-Device Interface Problem (2949); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	05/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that she received second degree burns to her stomach and left leg from hot water that spilled when the bottom portion of her personal steam inhaler (vih200) detached.She stated that the device was in the locked position when she picked it up, and the bottom housing separated, causing the hot water to spill and resulting in multiple blisters.The consumer reported that she was treated in an emergency room, where she was diagnosed with second degree burns.The instructions for proper use have clear warnings that state "the appliance should always be placed on a firm, flat, waterproof and heat-resistant surface.Be sure the appliance is in a stable position and the power cord is out of the way to prevent the appliance from being overturned.", as well as "caution: never move or disassemble the appliance while in use.It can spill hot water if tilted, shaken, or overturned which may lead to injury or burns.

• Brand Name: VICKS
• Common Device Name: PERSONAL STEAM INHALER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01752
• Manufacturer Contact: bethany lee ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752 ; 5084907247
• MDR Report Key: 25566624
• Report Number: 1314800-2026-00010
• Device Sequence Number: 10249726
• Product Code: KFZ
• UDI-Device Identifier: 00328785502008
• UDI-Public: 00328785502008
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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: VIH200
• Device Lot Number: 21325D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• 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: Other
• Patient Sex: Female