MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI SUNBEAM; HEATING PAD

Model Number 2013-470

Device Problems Thermal Decomposition of Device (1071); Hole In Material (1293); Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Consumer admits to sleeping while using the heating pad which is a violation of the instructions and warnings provided.Consumer has not returned the product.

Event Description

Consumer states she was using a heating pad in bed and fell asleep.When she awoke in the morning she smelled burning and is alleging that her heating pad had a burn hole in it.There was not a report of injury with this incident.

• Brand Name: SUNBEAM
• Type of Device: HEATING PAD
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI; 2381 executive center dr.; boca raton FL 33431
• Manufacturer (Section G): SKY EAGLE HOLDINGS CORP.; no. 128,chung hwa rd.,sec. 2,; taipei hsien, china (taiwan) 236 ; TW 236
• Manufacturer Contact: tracie jones ; p.o. box 2931; wichita, KS 67201 ; 3162197325
• MDR Report Key: 6028608
• MDR Text Key: 57862244
• Report Number: 3007790958-2016-00167
• Device Sequence Number: 1
• Product Code: IRT
• 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: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2013-470
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1