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

Device Problem Insufficient Information (3190)

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

Event Type  Injury  

Event Description

Consumer claims she was using a heating pad and allegedly sustained 3rd degree burns to her elbow.

Manufacturer Narrative

A prepaid label has been 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.; 2381 exectutive center drive; boca raton FL
• Manufacturer (Section G): SKYEAGLE HOLDINGS CORP; no. 128, chung hwa rd. sec. 2, tucheg; taipei hsien 0000 ; CH 0000
• Manufacturer Contact: tracie jones ; po box 2391; wichita, KS 67201 ; 3162197325
• MDR Report Key: 3736066
• MDR Text Key: 18365168
• Report Number: 3007790958-2014-00061
• 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: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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