MAUDE Adverse Event Report: VICKS; PERSONAL STEAM INHALER

Model Number	VIH200
Medical Device Problem Codes	Use of Device Problem (1670); Malposition of Device (2616); Device Handling Problem (3265); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	11/14/2020
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 her son received second degree burns on her his left thigh from hot water that spilled from the personal steam inhaler when the product was accidentally dropped.Medical intervention was sought for his injuries, as well as follow up care at a burn unit.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 "do not move, lift, shake, tilt or disassemble while in operation or if it still contains hot water".Kaz usa, inc.Has requested that the product be returned to our company for testing.

• Brand Name: VICKS
• Common Device Name: PERSONAL STEAM INHALER
• MDR Report Key: 11015706
• Report Number: 1314800-2020-00040
• Device Sequence Number: 3595173
• Product Code: KFZ
• UDI-Device Identifier: 00328785502008
• UDI-Public: 00328785502008
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

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: VIH200
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/16/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 10 YR