MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY SOFTHEAT; HEATING PAD

Model Number HP980

Device Problems Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 02/09/2018

Event Type  Injury  

Manufacturer Narrative

Kaz usa, inc.Has requested that the product be returned for testing, but it has not yet been received.

Event Description

A consumer stated that she had allegedly received burns on her left hip while using a heating pad almost 2 years ago, and medical attention was sought for her injuries.She stated that she received second and third degree burns, along with nerve damage, and that follow-up and surgery was needed due to an infection.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 instructions for proper use clearly state "danger: if used improperly, this product can cause severe burns to skin, and damage to property.", "do not use while sleeping.", and "this heating pad is intended for use on top of your body.Do not sit or lie on top of the heating pad.Never place pad between yourself and chair, sofa, bed or pillow." kaz usa, inc.Has requested that the product be returned to our company for testing.

Event Description

A consumer stated that she had allegedly received burns on her left hip while using a heating pad almost 2 years ago, and medical attention was sought for her injuries.She stated that she received second and third degree burns, along with nerve damage, and that follow-up and surgery was needed due to an infection.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 instructions for proper use clearly state ""danger: if used improperly, this product can cause severe burns to skin, and damage to property.", "do not use while sleeping.", and "this heating pad is intended for use on top of your body.Do not sit or lie on top of the heating pad.Never place pad between yourself and chair, sofa, bed or pillow.".

• Brand Name: SOFTHEAT
• Type of Device: HEATING PAD
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; 400 donald lynch boulevard; suite 300; marlborough MA 01752
• MDR Report Key: 11255014
• MDR Text Key: 229528159
• Report Number: 1314800-2021-00001
• Device Sequence Number: 1
• Product Code: IRT
• UDI-Device Identifier: 00328785000009
• UDI-Public: 0328785000009
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

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: HP980
• Device Lot Number: 15618GMT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/29/2021
• Supplement Dates Manufacturer Received: 12/30/2020
• Supplement Dates FDA Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention