MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY HONEYWELL; WARM MIST HUMIDIFIER

Model Number	HWM705B
Medical Device Problem Codes	Use of Device Problem (1670); Device Handling Problem (3265); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Burn(s) (1757); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Date of Event	04/29/2022
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 daughter received severe burns on her arm, hand, and wrist are from hot steam coming from a warm mist humidifier during use.Medical intervention was sought for her injuries, as well as follow-up care visits with burn specialists.The product displays a clear warning on the cord that states, "warning keep out of reach of children hot steam can cause serious burn injury" and the instructions for proper use also have clear warnings that state "warning: keep out of reach of children and pets.This product produces hot steam and should be placed in an area not accessible to children or pets.Ensure the power cord is also securely out of reach".Kaz usa, inc.Has requested that the product be returned to our company for testing.
Event or Problem Description
A consumer reported that her daughter received severe burns on her arm, hand, and wrist are from hot steam coming from a warm mist humidifier during use.Medical intervention was sought for her injuries, as well as follow-up care visits with burn specialists.The product displays a clear warning on the cord that states, "warning keep out of reach of children hot steam can cause serious burn injury" and the instructions for proper use also have clear warnings that state "warning: keep out of reach of children and pets.This product produces hot steam and should be placed in an area not accessible to children or pets.Ensure the power cord is also securely out of reach".

• Brand Name: HONEYWELL
• Common Device Name: WARM MIST HUMIDIFIER
• 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: 14647173
• Report Number: 1314800-2022-00014
• Device Sequence Number: 5719980
• Product Code: KFZ
• UDI-Device Identifier: 70092926007057
• UDI-Public: 00092926007058
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 12/01/2022

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: HWM705B
• Device Lot Number: 22917KUO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2017
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 3 YR
• Patient Sex: Female