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

Model Number	2100-WGN
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Use of Device Problem (1670)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that she received third degree burns on her arm from the hot steam that was being produced by the vaporizer during use.She stated that her injuries occurred when she quickly reached over the steam output during use.Medical intervention was sought for her injuries six days after the incident occurred.The instructions for proper use have clear warnings which state "do not touch the steam vapor.Steam can cause burns.", as well as a warning on the device itself which states, "warning keep out of reach of children hot steam can cause serious burn injury." kaz usa, inc.Has requested that the product be returned to our company for testing.
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.

• Brand Name: WALGREENS
• Common Device Name: VAPORIZER
• 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: 13388766
• Report Number: 1314800-2022-00003
• Device Sequence Number: 11223288
• Product Code: KFZ
• UDI-Device Identifier: 00049022459779
• UDI-Public: 00049022459779
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 01/26/2022

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: 2100-WGN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Sex: Female