MAUDE Adverse Event Report: KAZ USA, INC. CVS PHARMACY; HUMIDIFIER

Model Number GIH-120

Device Problem Break (1069)

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

Event Date 12/29/2015

Event Type  Injury  

Event Description

A consumer reported that the unit came apart during use, and this resulted in burns to this left thigh, and 2nd degree burns to his daughter's left torso and arm 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 overnight at a burn 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.

• Brand Name: CVS PHARMACY
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): KAZ USA, INC.; marlborough MA 01752
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch blvd., suite 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 5427264
• MDR Text Key: 37963436
• Report Number: 1314800-2016-00008
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: GIH-120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 3 YR