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

Model Number V1300

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

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

Event Date 09/09/2016

Event Type  Injury  

Manufacturer Narrative

Kaz usa, inc.Has requested that the product be returned to our company for testing, but the unit has not yet been returned.

Event Description

A consumer reported that the unit came apart during use, and this resulted in 2nd degree burns on her chest from the hot water that spilled out of the personal steam inhaler.Medical intervention was sought for their injuries four days after the incident occurred.The instructions for proper use have a clear warning that you should not fill the product with boiling water, and that in order to avoid hot water spilling after filling, be sure to properly secure top housing by twisting completely so it snaps back into place.Kaz usa, inc.Has requested that the product be returned to our company for testing.

• Brand Name: VICKS
• Type of Device: STEAM INHALER
• 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: 6039577
• MDR Text Key: 57811217
• Report Number: 1314800-2016-00053
• 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: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V1300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2016
• 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