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

Model Number 811-715

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Type  Injury  

Event Description

Consumer claims he fell asleep while laying on a heating pad and awoke the next morning with burn marks and water blisters.

Manufacturer Narrative

Consumer admits to sleeping with the heating pad which is a direct violation of the instruments and warnings provided.A prepaid label has been sent to the consumer for a 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; executive center dr; coxa raton FL 0000
• Manufacturer (Section G): SKYEAGLE HOLDINGS CORP; no. 128, chung hwa rd; sec.2; tucheg taipei hsien 0000 236; TW 0000236
• Manufacturer Contact: tracie jones ; po box 2391; wichita, KS 67201 ; 3162197325
• MDR Report Key: 3760979
• MDR Text Key: 4551079
• Report Number: 3007790958-2014-00071
• 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: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 811-715
• 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