MAUDE Adverse Event Report: CVSHEALTH; WARM STEAM VAPORIZER

Model Number	GVP110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Kaz usa, inc.Has requested that the product be returned for testing, but the item has not yet been received.
Event or Problem Description
A consumer stated she received second degree burns from hot steam that was spitting out of their vaporizer.It is unknown whether the woman received medical treatment for her injuries.The instructions for proper use have very clear warnings that state "the vaporizer should always be placed on a firm, flat, waterproof surface at least four feet away from bedside and out of reach of patients, children, and pets", and "caution: too much salt can cause excessive boiling".Kaz usa, inc.Has requested that the product be returned for testing.

• Brand Name: CVSHEALTH
• Common Device Name: WARM STEAM VAPORIZER
• MDR Report Key: 12311845
• Report Number: 1314800-2021-00015
• Device Sequence Number: 3181034
• Product Code: KFZ
• UDI-Device Identifier: 00050428372609
• UDI-Public: 00050428372609
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2021

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: GVP110
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 08/12/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention