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

Model Number V745A

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/16/2014

Event Type  Other  

Event Description

A consumer called and stated and stated that the tank handle broke off of their humidifier after it was filled with water.The tank then fell onto their wife's foot, and she was taken to the hospital and treated for a fractured foot.This is contrary to the proper handling of the device per the instructions for use which states that one should carry the water tank using one hand on the top handle and one on the bottom of the tank.

• 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: 3800537
• MDR Text Key: 4479342
• Report Number: 1314800-2014-00046
• Device Sequence Number: 1
• Product Code: KFZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V745A
• Device Lot Number: 20811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2014
• Initial Date FDA Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2011
• 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