MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC. DBA JARDEN CONSUMER SOLUTIONS, 2381 SUNBEAM; HEATING PAD

Model Number 536-912

Device Problems Fire (1245); Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Consumer claims the controller of his heating pad was getting too hot and burst into flames.No injuries or property damages were reported with this incident.

• Brand Name: SUNBEAM
• Type of Device: HEATING PAD
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC. DBA JARDEN CONSUMER SOLUTIONS, 2381; executive center drive; boca raton FL
• Manufacturer (Section G): SKYEAGLE HOLDINGS CORP; no. 128 chung hwa road; sect 2, tucheq; taipei hsien 236 ; TW 236
• Manufacturer Contact: tracie jones ; p.o. box 2391; wichita, KS 2391 ; 3162197325
• MDR Report Key: 3716518
• MDR Text Key: 21523304
• Report Number: 3007790958-2014-00055
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 536-912
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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