MAUDE Adverse Event Report: KAZ INC. VICKS; HUMIDIFIER

Model Number V1200

Device Problems Fluid/Blood Leak (1250); Device Tipped Over (2589)

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

Event Date 03/01/2014

Event Type  Other  

Event Description

The consumer called to report that he received second degree burns on his hand by hot water that spilled out of the personal steam inhaler.He reported that he had tipped the unit which caused the water to spill.The proper use instructions state to only use the unit on a firm level surface to avoid spilling the water.Medical intervention was not required for this incident.

• Brand Name: VICKS
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): KAZ INC.; 250 turnpike rd; southborough MA 01772
• Manufacturer (Section G): KAZ, INC.; 250 turnpike road; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike road; southborough, MA 01772 ; 5084907236
• MDR Report Key: 3788321
• MDR Text Key: 4442131
• Report Number: 1314800-2014-00038
• 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: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V1200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2014
• 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): Other