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

Model Number	VIH200C
Medical Device Problem Codes	Use of Device Problem (1670); Human-Device Interface Problem (2949); Device Handling Problem (3265); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A consumer reported that while using a vicks steam inhaler (model vih200c), the device allegedly opened unexpectedly despite being properly locked, causing hot water to spill onto their sister's chest and stomach and onto the consumer's right hand.The sister allegedly sustained burns and blistering, while the consumer reported burns to all fingers, which became black and swollen.Both individuals reportedly sought emergency medical treatment and received burn care, medication, and follow-up.The incident allegedly aggravated the sister's pre-existing breathing condition and caused emotional distress for both parties.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".
Event or Problem Description
A consumer reported that while using a vicks steam inhaler (model vih200c), the device allegedly opened unexpectedly despite being properly locked, causing hot water to spill onto their sister's chest and stomach and onto the consumer's right hand.The sister allegedly sustained burns and blistering, while the consumer reported burns to all fingers, which became black and swollen.Both individuals reportedly sought emergency medical treatment and received burn care, medication, and follow-up.The incident allegedly aggravated the sister's pre-existing breathing condition and caused emotional distress for both parties.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".

• 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
• MDR Report Key: 23244180
• Report Number: 1314800-2025-00026
• Device Sequence Number: 10236589
• Product Code: KFZ
• UDI-Device Identifier: 00328785012835
• UDI-Public: (01)00328785012835
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 12/20/2025

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: VIH200C
• Device Lot Number: 17824D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 12/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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; Required Intervention
• Patient Sex: Unknown