MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTIONS SUNBEAM; HUMIDIFIER

Model Number SWM2411

Device Problem Insufficient Information (3190)

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

Event Type  Injury  

Event Description

Consumer states she received a burn to her arm when hot water spilled from the humidifier as she emptied it into the sink.She sought medical treatment and was diagnosed with a 2nd degree burn.

Manufacturer Narrative

Consumer was emptying water from the humidifier when the water was still hot, this is a misuse of the product and a direct violation of the instructions and warnings provided.

• Brand Name: SUNBEAM
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTIONS; 2381 executive center drive; bocaraton FL
• Manufacturer (Section G): DONGGUAN HUIXAN ELECTRICAL PRODUCTS CO.; no.9112, hung yeh 8th road; tangxia town,dongguan ; CH
• Manufacturer Contact: tracie jones, ; p.o. box 2931; wichita, KS 67201 ; 3162197325
• MDR Report Key: 3600546
• MDR Text Key: 4070956
• Report Number: 3003862163-2014-00010
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: SWM2411
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• 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