MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI HOLMES; COOL MIST HUMIDIFIER

Model Number HN630-NU

Device Problems Break (1069); Component Falling (1105)

Patient Problems Fall (1848); Injury (2348)

Event Date 12/29/2015

Event Type  No Answer Provided  

Manufacturer Narrative

This incident did not occur because of any malfunction / defect of our product.Consumer tripped on the carpet.

Event Description

Consumer is claiming that while carrying the water tank of a humidifier, he tripped on the carpet and fell.The tank allegedly shattered and cut his face.

• Brand Name: HOLMES
• Type of Device: COOL MIST HUMIDIFIER
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI; 2381 executive center dr.; boca raton FL 33431
• 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: 5398607
• MDR Text Key: 37531122
• Report Number: 3003862163-2016-00017
• 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: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HN630-NU
• Was Device Available for Evaluation?: No
• 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