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

Model Number	V150SGNL
Medical Device Problem Codes	Use of Device Problem (1670); Human-Device Interface Problem (2949); Device Handling Problem (3265); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	07/08/2024
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 stated that she attempted to move the vaporizer from one room to another during operation, which caused the unit to spill hot water onto her left arm.The consumer stated that this allegedly caused third degree burns, but also stated that medical attention was not needed for these injuries.The instructions for proper use have very clear warnings that state, "the appliance should always be unplugged and emptied when not in operation or while being cleaned.Unplug vaporizer and allow to cool before moving.Do not move or tilt vaporizer while it is in operation.Plug and unplug unit with dry hands.Never pull by cord." kaz usa, inc.Has requested that the product be returned to our company for testing.

• Brand Name: VICKS
• Common Device Name: VAPORIZER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01752
• Manufacturer Contact: bethany lee ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752
• MDR Report Key: 19937530
• Report Number: 1314800-2024-00015
• Device Sequence Number: 17365982
• Product Code: KFZ
• UDI-Device Identifier: 00328785101508
• UDI-Public: 00328785101508
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 07/10/2024

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: V150SGNL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female