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

Model Number HWM-340BC

Device Problem Use of Device Problem (1670)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 10/21/2018

Event Type  Injury  

Manufacturer Narrative

Kaz usa, inc.Has requested that the product be returned for testing, but the item has not yet been received.

Event Description

A consumer called and stated that their infant child received burns from the hot steam that was coming out of their warm mist humidifier.The child received medical treatment at a hospital for a second degree burn on his hand, and he also required follow up care for his injuries.The instructions for proper use have very clear warnings that state, "warning: keep out of reach of children.This product produces hot steam and should be placed in an area not accessible to children or pets with the power cord also securely out of reach" and "caution: hot steam may cause burns".Kaz usa, inc.Has requested that the product be returned for testing, but it has not yet been received.

• 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: 8133375
• MDR Text Key: 129341199
• Report Number: 1314800-2018-00036
• Device Sequence Number: 1
• Product Code: KFZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HWM-340BC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention