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	Burn(s) (1757)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that while using a vicks steam inhaler (model vih200) as intended, the water reservoir allegedly loosened and detached during operation, purportedly causing hot water to spill onto the consumer's left thigh and resulting in a burn.The consumer allegedly sought medical evaluation from a physician.According to the certified physician assistant's note in the accompanying medical file, the consumer allegedly suffered a hot water burn to the left thigh resulting in a superficial burn.The consumer later reported that the original unit that caused the burn was returned to amazon.Com after it allegedly stopped heating.The consumer received a replacement unit and provided the lot code of the second unit as 07425.No additional medical outcome was reported.The instructions for proper use have clear warnings that state "caution: never move the appliance while in use.It can spill hot water if tilted, shaken or tipped over causing injury or burns", "do not move, lift, shake, tilt or disassemble while in operation or if it still contains hot water", as well as "allow the appliance to cool for at least 20 minutes before moving or refilling it".Kaz usa, inc.Has requested that the product be returned to our company for testing.
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: 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: 24341219
• Report Number: 1314800-2026-00004
• Device Sequence Number: 11964780
• Product Code: KFZ
• UDI-Device Identifier: 00328785502008
• UDI-Public: 00328785502008
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 02/14/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male