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

Model Number V1200

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

Event Date 09/30/2016

Event Type  Injury  

Manufacturer Narrative

Kaz usa, inc.Has requested that the product be returned for testing, but the consumer is refusing to do so.

Event Description

A consumer reported that the unit leaked, and this resulted in burns to his son from the hot water that spilled out of the personal steam inhaler.Medical intervention was sought for their injuries, and it was stated that they the child was treated at a wound center.The instructions for proper use have a clear warning that the product should only be used on a flat level surface to avoid spilling water, and also to keep out of reach of children.Kaz usa, inc.Has requested that the product be returned to our company for testing, but the consumer has refused to do so.

Event Description

A consumer reported that the unit leaked, and this resulted in burns to his son from the hot water that spilled out of the personal steam inhaler.Medical intervention was sought for their injuries, and it was stated that they the child was treated at a wound center.The instructions for proper use have a clear warning that the product should only be used on a flat level surface to avoid spilling water, and also to keep out of reach of children.

• 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: 6063448
• MDR Text Key: 58659852
• Report Number: 1314800-2016-00056
• 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 Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 11/21/2016

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: V1200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 10/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2016
• 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): Hospitalization; Other
• Patient Age: 5 YR