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); Device Handling Problem (3265); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	10/23/2021
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 their infant had a cough, and they were using a personal steam inhaler on the child.The baby allegedly received second degree burns on his arm from hot water that spilled from the personal steam inhaler during use.Medical intervention was sought for his injuries at an emergency room.The instructions for proper use have clear warnings that state "caution: do not place on lap or lift in your hands while in operation and if the unit still contains water", "the appliance should not be left unattended.Keep out of reach of children", and "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: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 15639244
• Report Number: 1314800-2022-00019
• Device Sequence Number: 6387234
• Product Code: KFZ
• UDI-Device Identifier: 00328785002492
• UDI-Public: 00328785002492
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/20/2022

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 12 MO
• Patient Sex: Male