MAUDE Adverse Event Report: VICKS; STEAM INHALER

Model Number	V1200
Medical Device Problem Codes	Use of Device Problem (1670); Device Tipped Over (2589)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	09/13/2020
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 the product was already returned/discarded.
Event or Problem Description
A consumer reported that she received second degree burns on her chest from hot water that spilled from the personal steam inhaler.Medical intervention was sought for her injuries.The instructions for proper use have a clear warning that states "the appliance should always be placed on a firm, flat waterproof surface", "caution: do not place on lap or lift in your hands while in operation and if the unit still contains water", and "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, but the consumer stated that they had already returned it.

• Brand Name: VICKS
• Common Device Name: STEAM INHALER
• MDR Report Key: 10667015
• Report Number: 1314800-2020-00036
• Device Sequence Number: 14239359
• Product Code: KFZ
• UDI-Device Identifier: 00328785002492
• UDI-Public: 00328785002492
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/13/2020

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: V1200
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/12/2020
• 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: Required Intervention
• Patient Age: 26 YR