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

Model Number 536-912

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 02/01/2014

Event Type  Injury  

Event Description

Consumer claims she was sitting in bed using a heating pad.When she went to get up she discovered a burn on her buttock.Claims she sought medical treatment a few days later and was diagnosed with a 3rd degree burn.

Manufacturer Narrative

Consumer admits to sitting on the heating pad which is a direct violation of the instructions and warnings provided.There is an instruction that states, "burns can occur regardless of control setting, check skin under pad frequently" and consumer failed to perform that instruction.The pad has been requested from the consumer to determine if the incident arose from abuse/misuse of the pad (i.E.Bunching/folding/crushing).A prepaid label was sent to the consumer for return of the product.Consumer has not returned the product.

• Brand Name: SUNBEAM
• Type of Device: HEATING PAD
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC, DBA JARDEN CONSUMER SOLUTIONS; 2381 executive center dr; boca raton FL
• Manufacturer (Section G): SKYEAGLE HOLDINGS CORP; no. 128 chung hwa rd, sec. 2; tucheg taipei hsien 236 ; TW 236
• Manufacturer Contact: tracie jones ; p.o. box 2391; wicita, KS 67201 ; 3162197325
• MDR Report Key: 3834397
• MDR Text Key: 4400999
• Report Number: 3007790958-2014-00088
• 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: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 536-912
• 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