MAUDE Adverse Event Report: KAZ USA, INC SOFTHEAT; HEATING PAD

Model Number HP215

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 01/09/2014

Event Type  Other  

Event Description

A consumer sent a letter to report that she had allegedly been burned by a heating pad.This incident resulted in third degree burns on her thigh.The pt stated that she is being treated weekly at a wound care clinic.Burns of this nature are most likely caused by the consumer laying or leaning against the pad which is contrary to proper use instruction.The product has a clear warning that states the product is intended for use on top of the body, and consumers should not sit against or lay on top of the heating pad.The instructions also have a warning to never place the pad between yourself and a chair, sofa, bed, or pillow.

• Brand Name: SOFTHEAT
• Type of Device: HEATING PAD
• Manufacturer (Section D): KAZ USA, INC; 250 turnpike rd; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike rd; southborough, MA 01772 ; 5084907236
• MDR Report Key: 3802923
• MDR Text Key: 22139241
• Report Number: 1314800-2014-00048
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HP215
• Device Lot Number: 24013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other