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

Model Number VIH200

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

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

Event Date 02/17/2023

Event Type  Injury  

Event Description

A consumer reported that her daughter received second degree burns on her thighs from hot water that spilled from the personal steam inhaler.She stated that the bottom portion of the unit became loose while she was holding the device near her daughter's face and hot water spilled out of the unit onto the child, resulting in her injuries.Medical intervention was sought at an urgent care clinic.The instructions for proper use have clear warnings that state "keep out of reach of children", "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.

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 her daughter received second degree burns on her thighs from hot water that spilled from the personal steam inhaler.She stated that the bottom portion of the unit became loose while she was holding the device near her daughter's face and hot water spilled out of the unit onto the child, resulting in her injuries.Medical intervention was sought at an urgent care clinic.The instructions for proper use have clear warnings that state "keep out of reach of children", "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".

• 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 ; 5084907236
• MDR Report Key: 16743048
• MDR Text Key: 313331613
• Report Number: 1314800-2023-00006
• 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,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: VIH200
• Device Lot Number: 21622DEC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2022
• 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; Other; Required Intervention
• Patient Age: 6 YR
• Patient Sex: Female