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

Model Number V750

Device Problem Use of Device Problem (1670)

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

Event Date 11/26/2018

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 reported that the water tank exploded while she was filling it with hot water, which resulted in second degree burns.Medical intervention was sought for her injury.The instructions for proper use have a clear warning that states, "fill tank with cool water.Do not fill with warm or hot water." kaz usa, inc.Has requested that the product be returned to our company for testing.

• Brand Name: VICKS
• Type of Device: 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: 8230898
• MDR Text Key: 132496275
• Report Number: 1314800-2019-00004
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V750
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2018
• 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): Other; Required Intervention