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

Model Number VIH200V2

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949); Patient Device Interaction Problem (4001)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 12/30/2023

Event Type  Injury  

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 Description

A consumer reported that his wife received second degree burns on her leg from hot water that spilled from the personal steam inhaler.He stated that the top housing of the unit was not secured into place during use, and hot water spilled onto her leg causing injuries.The consumer stated that his wife was treated in an emergency room, and later also received follow up care from a burn specialist.The instructions for proper use have clear warnings that state "the appliance should always be placed on a firm, flat, waterproof and heat resistant surface.Be sure the appliance is in a stable position and the power cord is out of the way to prevent the appliance from being overturned.", as well as, "caution: never move or disassemble the appliance while in use.It can spill hot water if tilted, shaken, or overturned which may lead to injury or burns." kaz usa, inc.Has requested that the product be returned to our company for testing.

• Brand Name: VICKS
• Type of Device: 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
• MDR Report Key: 19002878
• MDR Text Key: 338888977
• Report Number: 1314800-2024-00007
• Device Sequence Number: 1
• Product Code: KFZ
• UDI-Device Identifier: 00328785502008
• UDI-Public: 00328785502008
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: VIH200V2
• Device Lot Number: 20122
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Sex: Female