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

Model Number 901-9

Device Problem Smoking (1585)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Consumer was using the heating pad after back surgery.She alleges that after 40 minutes of use her nurse removed the heating pad and it was smoking.She claims to have suffered a 2nd degree burn which was treated with burn cream.

Manufacturer Narrative

Pad has been bunched/crushed which is an abuse of the product and a violation of the warnings and instructions provided.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.This incident is the direct result of consumer misuse/abuse of the product.

• Brand Name: SUMBEAM
• 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): POWERTEK ELECTRONIC CO., LTD.; zhixiang bldg., 6th floor, 71 block; bao-an, shenzhen, guangdong ; CH
• Manufacturer Contact: tracie jones ; po box 2391; wichita, KS 67201 ; 3162197325
• MDR Report Key: 3836116
• MDR Text Key: 4453977
• Report Number: 3005477599-2014-00087
• 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: Unknown
• Type of Report: Initial
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 901-9
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2014
• Initial Date FDA Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• 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