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

Model Number HP5OS-CAN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Unspecified Infection (1930); Partial thickness (Second Degree) Burn (2694)

Event Date 04/02/2014

Event Type  Other  

Event Description

A consumer called to report that she had allegedly been burned by a heating pad.This incident resulted in blisters on her right thigh, which resulted in an infection.The patient is currently being treated by her physician and has been prescribed antibiotics.Burns of this nature are most likely caused by the consumer laying or leaning against the pad which is contrary to proper instructions.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 road; southborough MA 01772
• Manufacturer (Section G): KAZ, INC.; one vapor trail; hudson NY 12534
• Manufacturer Contact: sonja wilkinson ; 250 turnpike road; southborough, MA 01772 ; 5084907236
• MDR Report Key: 3788322
• MDR Text Key: 17384029
• Report Number: 1314800-2014-00042
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/23/2014

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: Lay User/Patient
• Device Model Number: HP5OS-CAN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 04/25/2014
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other