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

Model Number V150SG

Device Problem Use of Device Problem (1670)

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

Event Date 09/03/2018

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 she received 2nd degree burns from boiling water while filling her warm steam vaporizer.She stated that she was treated at a hospital for her injuries.The instructions for proper use have clear warnings which states that, "it is a device that produces hot steam and could cause severe burns and injuries", and "do not remove the appliance head during operation or within 20-30 minutes after it is unplugged." kaz usa, inc.Has requested that the product be returned for testing.

Event Description

A consumer reported that she received 2nd degree burns from boiling water while filling her warm steam vaporizer.She stated that she was treated at a hospital for her injuries.The instructions for proper use have clear warnings which states that, "it is a device that produces hot steam and could cause severe burns and injuries", and "do not remove the appliance head during operation or within 20-30 minutes after it is unplugged.".

• Brand Name: VICKS
• Type of Device: WARM STEAM VAPORIZER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01752
• MDR Report Key: 8464255
• MDR Text Key: 140305778
• Report Number: 1314800-2019-00019
• 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,Followup
• Report Date: 06/26/2019

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: V150SG
• Device Lot Number: 23317KTC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 03/01/2019
• Supplement Dates FDA Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention