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

Model Number 536

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Consumer claims she was having trouble sleeping so she took some nyquil and fell asleep while using a heating pad.She awoke to find burns to her tip and torso.She sought medical treatment and claims she was diagnosed with 1st and 2nd degree burns.

Manufacturer Narrative

Consumer admits to sleeping with the heating pad which is a direct violation of the instructions and warnings provided.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 executive center dr.; dba jarden consumer solutions; boca raton FL
• Manufacturer (Section G): SKY EAGLE HOLDINGS CORP.; eagle electric shenshen; 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: 3760977
• MDR Text Key: 4551078
• Report Number: 3007790958-2014-00070
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• 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: 536
• 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