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 Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 01/28/2018

Event Type  Injury  

Manufacturer Narrative

Kaz usa, inc.Has requested that the product be returned for testing, but the product has not yet been received.

Event Description

A consumer reported that she received first and second degree burns on her hand and stomach from hot water that spilled out of the personal steam inhaler.Medical intervention was sought for their injuries on the day that the incident occured, as well as follow up visits.The consumer stated that she was lifting the unit towards her face when the injury occurred.The instructions for proper use have a clear warning that states "the appliance should always be placed on a firm, flat waterproof surface", and "caution: do not place on lap or lift in your hands while in operation and if the unit still contains water." 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: 7308981
• MDR Text Key: 101359464
• Report Number: 1314800-2018-00010
• 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: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• 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: 22216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention