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

Model Number GIH120

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

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

Event Date 02/25/2017

Event Type  Injury  

Event Description

A consumer reported that her (b)(6) daughter was using the product, and received second degree burns from hot water that spilled out of the personal steam inhaler.It was stated that medical intervention was sought for her injuries.The instructions for proper use have a clear warning that states, "caution: do not place on lap or lift in your hands while in operation and if the unit still contains water.The appliance should not be left unattended.Keep out of reach of children." the consumer also stated that she was using liquid menthol medication in the water during this incident, and the instructions for use also states, "no medication or (b)(6)/pharmacy¿ vapor steam should be added directly to the water reservoir of the steam inhaler." kaz usa, inc.Has requested that the product be returned to our company for testing.

• Brand Name: CVS HEALTH
• 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: 6561505
• MDR Text Key: 74960312
• Report Number: 1314800-2017-00026
• 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
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: GIH120
• Device Lot Number: 25416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2016
• 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
• Patient Age: 24 MO