MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC. SUNBEAM; HEATING PAD

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 a heating pad during the night for her lower back and fell asleep.After 30 minutes she noticed she had two blisters on her buttocks.She is alleging that she suffered 2nd degree burns.

Manufacturer Narrative

Consumer admits to burns on her buttocks which indicates she was sitting / leaning on the heating pad which is abuse of the product and violation of the instructions and warnings provided.Consumer admits to falling asleep while using the pad which is abuse of the product and 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 performed that instruction.

• Brand Name: SUNBEAM
• Type of Device: HEATING PAD
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC.; 2381 executive center dr.; dba jarden consumer solutions; boca raton FL
• Manufacturer (Section G): SKY EAGLE HOLDINGS CORP.; sky eagle holdings corp.; no. 128, chung hwa. sec. 2 tucheg; taipei, hsien 236 ; TW 236
• Manufacturer Contact: tracie jones ; p.o. box 2391; wichita, KS 67201 ; 3162197325
• MDR Report Key: 3854838
• MDR Text Key: 4413279
• Report Number: 3007790958-2014-00092
• 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: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• 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