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

Model Number 732-500

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Type  Injury  

Event Description

Consumer claims she was using her heating pad on her thigh and fell asleep.She awoke to find burns on her leg and alleges she was diagnosed with second degree burns.

Manufacturer Narrative

Consumer admits to falling asleep with the heating pad which is a 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 (ie bunching/folding/crushing).A prepaid label was sent to the consumer for the 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 SOLUTOINS; 2381 executive center dr; boca raton FL
• Manufacturer (Section G): SKYEAGLE HOLDINGS CORP; no. 128 chung hwa rd; sec. 2, tucheg; taipei hsien 236 ; CH 236
• Manufacturer Contact: tracie jones ; po box 2391; wichita, KS 67201 ; 3162197325
• MDR Report Key: 3833430
• MDR Text Key: 4393265
• Report Number: 3007790958-2014-00091
• 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: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 732-500
• 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