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

Model Number	V1200-6
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); 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	09/22/2021
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 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 or Problem 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
• Common Device Name: 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
• Report Number: 1314800-2021-00019
• Device Sequence Number: 17070320
• Product Code: KFZ
• UDI-Device Identifier: 00328785002492
• UDI-Public: 00328785002492
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2021
• Supplement Date Received by Manufacturer: 09/25/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female