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

Model Number V150SG

Device Problems Unintended Ejection (1234); Fluid/Blood Leak (1250)

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

Event Date 03/14/2014

Event Type  Other  

Event Description

A consumer reported that they allegedly had received a burn from one of our vaporizers.The consumer alleges that the product shot water out of it, which caused a second degree burn on her foot.She was treated at a hospital, and is doing fine now.Kaz has requested that the unit be returned to our company for further investigation.

• Brand Name: VICKS
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): KAZ USA, INC.; 250 turnpike road; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike road; southborough, MA 01772 ; 5084907236
• MDR Report Key: 3777517
• MDR Text Key: 4435205
• Report Number: 1314800-2014-00029
• 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: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V150SG
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2014
• 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