MAUDE Adverse Event Report: NUK USA LLC NUK; COOL MIST HUMIDIFIER

Model Number 78103

Device Problems Burst Container or Vessel (1074); Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 11/29/2015

Event Type  Injury  

Manufacturer Narrative

Consumer admits to pouring hot water into the tank of the humidifier which is a misuse / abuse of the product and a direct violation of the instructions and warnings provided.

Event Description

Consumer is alleging that his humidifier's tank exploded after he filled it with hot water and that the hot water burned his arm and chest.

• Brand Name: NUK
• Type of Device: COOL MIST HUMIDIFIER
• Manufacturer (Section D): NUK USA LLC; 728 booster blvd.; reedsburge WI 53959
• MDR Report Key: 5331726
• MDR Text Key: 34570425
• Report Number: 2110540-2015-00001
• Device Sequence Number: 1
• Product Code: KFZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 12/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 78103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2015
• Distributor Facility Aware Date: 12/10/2015
• Event Location: Home
• Date Report to Manufacturer: 12/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other