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

Model Number	V1200
Medical Device Problem Codes	Use of Device Problem (1670); Human-Device Interface Problem (2949); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that her eight-year-old daughter received third degree burns to her thighs and stomach area from the hot water that spilled out of their vicks steam inhaler during use.The consumer alleged that during use the device suddenly released steam, resulting in injuries which required extensive medical treatment, including hospitalization, skin graft surgery, and follow up care.The instructions for proper use have clear warnings that state "the appliance should not be left unattended.Keep out of reach of children", "the appliance should always be placed on a firm, flat waterproof surface", "caution: do not place on lap or lift in your hands while in operation and if the unit still contains water" as well as, "never move the appliance while in use.It can spill hot water if tilted or tipped over causing injury.".

• 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: 19706502
• Report Number: 1314800-2024-00013
• Device Sequence Number: 17796383
• Product Code: KFZ
• UDI-Device Identifier: 00328785002492
• UDI-Public: 00328785002492
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 07/08/2024

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: V1200
• Device Lot Number: 05719MGH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2019
• 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; Disability; Hospitalization
• Patient Age: 8 YR
• Patient Sex: Female