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

Model Number 771

Device Problem Insufficient Information (3190)

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 02/03/2014

Event Type  Injury  

Event Description

Consumer claims she was using her heating pad on her hip and afterwards noticed that she had two blisters.She sought medical treatment where she claims she was diagnosed with third degree burns.

Manufacturer Narrative

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): SKY EAGLE HOLDINGS CORP, EAGLE ELECTRIC SHENSHEN; no. 128, chung hwa rd., sec. 2, tucheg; taipei hsien 236 ; TW 236
• Manufacturer Contact: tracie jones ; p.o. box 2391; wichita, KS 67201 ; 3162197325
• MDR Report Key: 3802914
• MDR Text Key: 17612741
• Report Number: 3007790958-2014-00078
• 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: 05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 771
• 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