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

Model Number V1200

Device Problems Use of Device Problem (1670); Device Handling Problem (3265); Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Scar Tissue (2060)

Event Date 12/09/2022

Event Type  Injury  

Event Description

A consumer reported that she received burns on her right arm and wrist from hot water that spilled from the personal steam inhaler.She stated that she went to pick the device up during use and the unit spurted out hot water / steam, which landed on her arm.The severity of the injuries is unknown, but the patient stated that she required medical attention at a hospital, and states that she still has skin dicoloration/scarring.The instructions for proper use have clear warnings that state "the appliance should always be placed on a firm, flat waterproof surface.Be sure the appliance is in a stable position and the power cord is out of the way to prevent the unit from being tipped over.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." kaz usa, inc.Has requested that the product be returned to our company for testing.

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
• Type of Device: PERSONAL STEAM INHALER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01752
• Manufacturer (Section G): KAZ USA, INC., A HELEN OF TROY COMPANY; 400 donald lynch boulevard; suite 300; marlborough MA 01752
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 16657280
• MDR Text Key: 312446758
• Report Number: 1314800-2023-00005
• Device Sequence Number: 1
• Product Code: KFZ
• UDI-Device Identifier: 00328785002492
• UDI-Public: 00328785002492
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V1200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Sex: Female