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

Model Number 536-515

Device Problems Fire (1245); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Consumer states she was laying on a heating pad for a migraine, she got up and left the room, leaving the heating pad "on" and unattended.She alleges that when she returned her heating pad had caught on fire and damaged her bedding.No injuries were reported with this incident.

Manufacturer Narrative

Consumer admits to laying on the heating pad which is abuse of the product and a violation of the instructions and warning provided.Consumer admits to leaving the heating pad "on" and unattended which is abuse of the product and a violation of the instructions and warning provided.A prepaid label was sent to the consumer for return of the product.However, consumer states that her cleaning crew threw out the product.

• Brand Name: SUNBEAM
• Type of Device: HEATING PAD
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTIONS; 2381 executive ctr dr; boca raton FL
• Manufacturer (Section G): SKYEAGLE HOLDINGS CORP, EAGLE ELECTRIC SHENSHEN; no. 128 chung hwa rd; sec. 2 tucheg; taipei hsien 236 ; TW 236
• Manufacturer Contact: tracie jones ; po box 2391; wichita, KS 67201 ; 3162197325
• MDR Report Key: 4892368
• MDR Text Key: 6021433
• Report Number: 3007790958-2015-00100
• 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: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 536-515
• 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