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

Model Number V750

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

Kaz usa, inc.Requested that the product be returned for testing, but the consumer stated that it had already been discarded.Therefore, the root cause of this complaint cannot be determined.

Event Description

We received a complaint from the fda's medwatch program, report number mw5072806.A consumer reported that their humidifier began smoking and caught fire.No adverse event was reported.Kaz usa, inc.Contacted the consumer on (b)(6) 2017, which is the same day that the medwatch report was received via the united states postal service.When we spoke directly with the consumer, they had stated that they had already discarded the unit and there was no way to retrieve it.The root cause for this specific complaint could not be determined since the product was not available for investigation.

• Brand Name: VICKS
• Type of Device: WARM MOISTURE 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: 7066499
• MDR Text Key: 93222404
• Report Number: 1314800-2017-00047
• Device Sequence Number: 1
• Product Code: KFZ
• 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: Patient
• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: V750
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other