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

Model Number HWM705B

Device Problems Use of Device Problem (1670); Device Handling Problem (3265); Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 04/29/2022

Event Type  Injury  

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 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 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
• Type of Device: 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
• MDR Text Key: 293683191
• Report Number: 1314800-2022-00014
• Device Sequence Number: 1
• Product Code: KFZ
• UDI-Device Identifier: 70092926007057
• UDI-Public: 00092926007058
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: HWM705B
• Device Lot Number: 22917KUO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 05/10/2022
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 3 YR
• Patient Sex: Female