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

Model Number HWM340W

Device Problem Use of Device Problem (1670)

Patient Problems Burn(s) (1757); Blister (4537)

Event Date 10/08/2021

Event Type  malfunction  

Event Description

A consumer reported that their humidifier allegedly caught fire in a bedroom, which resulted in smoke damage to her walls, property damage on the flooring, along with minor injury to her husband's foot.Medical attention had not been sought for his injuries.

• Brand Name: HONEYWELL
• Type of Device: WARM MIST HUMIDIFIER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01752
• MDR Report Key: 12753847
• MDR Text Key: 282199186
• Report Number: 1314800-2021-00023
• Device Sequence Number: 1
• Product Code: KFZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HWM340W
• Device Lot Number: 19319EAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Date Manufacturer Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2019
• 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): Other