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

Model Number V1200-6

Device Problems Unexpected Therapeutic Results (1631); Use of Device Problem (1670); Device Handling Problem (3265); Patient Device Interaction Problem (4001)

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

Event Date 09/22/2021

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 she received second degree burns on her arm and side from hot water that spilled from the personal steam inhaler during use.Medical intervention was sought for her injuries.The instructions for proper use have clear warnings that state "caution: never move or lift the inhaler while it is in use.Do not remove the inhaler hood and vent assembly after turning on the inhaler.Steam is produced by boiling water; tilting can cause water spill and possible burns", 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.

Event Description

A consumer reported that she received second degree burns on her arm and side from hot water that spilled from the personal steam inhaler during use.Medical intervention was sought for her injuries.The instructions for proper use have clear warnings that state "caution: never move or lift the inhaler while it is in use.Do not remove the inhaler hood and vent assembly after turning on the inhaler.Steam is produced by boiling water; tilting can cause water spill and possible burns", 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
• Type of Device: PERSONAL STEAM INALER
• 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: 12698623
• MDR Text Key: 278390371
• Report Number: 1314800-2021-00019
• 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,Followup
• Report Date: 11/15/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: V1200-6
• Device Lot Number: 31620MGH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Initial Date Manufacturer Received: 09/25/2021
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 09/25/2021
• Supplement Dates FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female