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); Device Handling Problem (3265); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	07/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that she received third degree burns on her thigh from hot water that spilled from the personal steam inhaler.She stated that she attempted to open the unit during use and hot water spilled out of the unit, resulting in her injuries.Medical intervention was sought for her injuries, as well as multiple follow up visits.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", 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: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 17498301
• Report Number: 1314800-2023-00010
• Device Sequence Number: 12360321
• Product Code: KFZ
• UDI-Device Identifier: 00328785502008
• UDI-Public: 00328785502008
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/10/2023

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: 18421
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2021
• 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; Hospitalization
• Patient Sex: Female