MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC. HOLMES; HUMIDIFIER

Model Number HM5082

Device Problems Fluid/Blood Leak (1250); Human-Device Interface Problem (2949)

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

Event Date 03/02/2014

Event Type  Injury  

Manufacturer Narrative

Consumer placed the humidifier within reach of a child which is a misuse of the product and a direct violation of the instructions and warnings provided.

Event Description

Consumer is claiming that she had a humidifier set up in her child's room and the child tried moving the humidifier causing hot water to spill on her leg.She is alleging the child suffered second degree burn on thigh, ankle and foot.

• Brand Name: HOLMES
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC.; 2381 executive center drive; dba jarden consumer solutions; boca raton FL
• Manufacturer (Section G): DONGGUAN HUIXAN ELECTRICAL PRODUCTS CO.LTD; no.9-12,hung yeh 8th road; tangxia town,dongguan ; CH
• Manufacturer Contact: tracie jones ; po box 2931; wichita, KS 67201 ; 3162197325
• MDR Report Key: 3779388
• MDR Text Key: 15876696
• Report Number: 3003862163-2014-00074
• 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: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: HM5082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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
• Patient Outcome(s): Other