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

Model Number 835-915

Device Problems Thermal Decomposition of Device (1071); Hole In Material (1293); Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Event Description

Consumer is alleging she was using the heating pad while in bed and discovered a hole burned in the pad and a burn on her back.

• 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: 4727935
• MDR Text Key: 5746214
• Report Number: 3007790958-2015-00070
• 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: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 835-915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2015
• 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